Contact Lenses and Eyeglasses

Number: 0126

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses contact lenses and eyeglasses.

1. Medical Necessity

   Note: Many Aetna medical plans exclude coverage of contact lenses or eyeglasses.  Under medical plans with this exclusion, contact lenses are only covered under medical plans for a narrow set of therapeutic indications, as outlined below.  Additional coverage of contact lenses and eyeglasses may be provided under the member's vision care plan, if any.  Please check benefit plan descriptions for details.

   1. Replacement Eyeglasses Under Plans With a Pediatric Vision Benefit

      Some plans include a pediatric vision benefit. Please check benefit plan descriptions. Under these plans, replacement lenses are considered medically necessary for children and adolescents when one or more of the following criteria are met:

      1. There is a change in refractive error; or
      2. With regular use, the previous eyeglasses were broken or marred to a degree significantly interfering with vision or eye safety; or
      3. The eyeglasses are replaced because a different frame size or shape is necessary due to the child's growth, metal allergy or other justifiable medical reasons.

   2. Prosthetic Contact Lenses and Eyeglasses for Aphakia

      1. Medicare plans and HMO plans (HMO, QPOS)

         For Aetna Medicare plans and Aetna HMO plans, Aetna follows Medicare's rules for prosthetic lenses.

         For Aetna Medicare members and HMO members, Aetna considers external lenses (contacts or spectacles) and intraocular lenses medically necessary after cataract surgery.  Centers for Medicare and Medicaid Services (CMS) defines both types of lenses as “prostheses” replacing the lens of the eye.  This includes post-surgical external lenses that are customarily used during convalescence from cataract removal surgery.  In addition, an intraocular lens is considered a medically necessary prosthetic for individuals lacking an organic lens because of surgical removal (e.g., cataract surgery) or congenital absence (congenital aphakia).  Note: Aetna covers medically necessary external and internal lenses as prosthetics for aphakic members even if the surgical removal of the member's lens occurred before the member enrolled in Aetna's medical plan.

         For Medicare and HMO members, Aetna considers lenses or combinations of lenses medically necessary following cataract surgery to essentially restore the vision provided by the crystalline lens of the eye, including:

         • Bifocal spectacles; or
         • Spectacles for far vision or for near vision; or
         • Aetna considers contact lenses for far vision (including cases of binocular and monocular aphakia) medically necessary, including both the contact lens(es) and spectacles for near vision that are worn either simultaneously with the contact lenses or when the contact lenses have been removed.

         For Medicare members and HMO members, Aetna medical plans consider lenses with ultraviolet (UV) protection medically necessary in lieu of regular (untinted) lenses for aphakia.  UV coating is considered medically necessary when applied to a glass lens material.

         Anti-reflective coating, tints, or oversize lenses are not generally considered medically necessary; the medical necessity of such features must be documented by the treating physician.

         Aetna considers cataract sunglasses (i.e., tinted lenses, including photochromatic lenses (lenses in which the tint changes in response to light)) that are prescribed in addition to regular (untinted) lenses for aphakia medically necessary because the sunglasses duplicate the restoration of vision function performed by the regular lenses.

         Aetna considers the following features not medically necessary:

         • Eyeglass cases;
         • Mirror coating (colored, highly-reflective lens treatments);
         • Polarization;
         • Progressive lenses (i.e., multifocal lens that gradually changes in lens power from the top to the bottom of the lens, eliminating the lines that would otherwise be seen in a bifocal or trifocal lens);
         • Scratch resistant coating.

         Lenses made of polycarbonate or other impact-resistant materials (e.g., Trivex) are considered medically necessary for members with functional vision in only one eye.  Use of polycarbonate or similar material or high index glass or plastic for indications such as light weight or thinness is considered not medically necessary.

         Standard eyeglass frames are considered medically necessary for persons who meet criteria for refractive lenses.  Deluxe frames are considered convenience items.

         Under Medicare and HMO plans, Aetna considers eyewear a medically necessary prosthetic for aphakic members who have not had an intraocular lens replacement. Additionally, Aetna considers aphakic contact lenses medically necessary under Medicare and HMO plans as prosthetics for infants with aphakia after congenital cataract surgery and who have not had intraocular lens implantation. Aphakic members lack an internal lens where their contact lenses or eyeglasses are considered to be prosthetics.  For Medicare and HMO plans, Aetna medical plans consider medically necessary the first pair of glasses or aphakia contact lenses after cataract surgery and an additional pair of lens(es) each time the member's prescription changes.  Requests for replacement of lost or broken glasses or lenses will be reviewed on an individual basis. (There is a CMS requirement for consideration of replacement of lost or broken contact lenses or eyeglasses for Medicare members who have had cataract surgery.)

         Note: For Medicare and HMO members who have had cataract surgery with insertion of an intraocular lens (IOL), Aetna Medicare and HMO plans, by administration, will cover no more than 1 pair of eyeglasses or contact lenses after each cataract surgery.  Replacements of conventional eyeglasses or contact lenses are not covered under these medical plans.  The member may have additional eyewear coverage through a vision care rider.

      2. Traditional (non-HMO) plans (Indemnity, PPO and MC POS plans)

         While contact lenses and eyeglasses are rarely used in place of intraocular lenses in aphakia, contact lenses and eyeglasses are considered medically necessary under traditional medical plans as a prosthetic device following cataract surgery in lieu of intraocular lenses. Additionally, Aetna considers aphakic contact lenses medically necessary under traditional plans as prosthetics for infants with aphakia after congenital cataract surgery and who have not had intraocular lens implantation. Aphakic members lack an internal lens where their contact lenses or eyeglasses are considered to be prosthetics. For traditional plans, Aetna medical plans consider medically necessary the first pair of glasses or aphakia contact lenses after cataract surgery and an additional pair of lens(es) each time the member's prescription changes. Note: Most Aetna plans exclude coverage of contact lenses and spectacles.  Under these plans, eyeglasses and contact lenses in non-aphakic members, including those who have had intraocular lenses implanted after cataract surgery, are not covered under medical plans.  Contact lenses and eyeglasses may be covered under the member's vision care plan.

   3. Therapeutic Hydrophilic Contact Lenses (Corneal Bandage)

      Therapeutic soft (hydrophilic) contact lenses or gas-permeable fluid ventilated scleral lenses (e.g., Boston Scleral Lens and PVR PROSE Scleral Lens) are considered medically necessary prosthetics under medical plans where used as moist corneal bandages for the treatment of severe ocular surface diseases, including

      1. Corneal stem cell deficiency (Stevens-Johnson syndrome/TEN, chemical and thermal injuries to the eye including surgical procedures, aniridia, idiopathic corneal stem cell deficiency and ocular pemphigoid); or
      2. Neurotrophic (anesthetic) corneas, such as may result from:
         
         
         1. Acquired etiologies, such as may result from acoustic neuroma surgery, trigeminal ganglionectomy, trigeminal rhyzotomy, herpes simplex/zoster of the cornea, diabetes; or
         2. Congenital etiologies, such as congenital corneal anesthesia (familial dysautonomia), Seckle's syndrome; or
      3. Severe dry eyes (keratoconjunctivitis sicca) (such as from Sjogren's syndrome, chronic graft versus host disease, radiation, surgery, meibomian gland deficiency); or
      4. Corneal disorders associated with systemic autoimmune diseases (rheumatoid arthritis, dermatological disorders such as atopic, epidermolysis bullosa, epidermal dysplasia); or
      5. Epidermal ocular disorders (atopy, ectodermal dysplasia, epidermolysis bullosa); or
      6. Corneal exposure (e.g., anatomic, paralytic).

      Note: Liquid bandage scleral lenses are covered under plans that exclude coverage of contact lenses, as these lenses are not primarily for correction of refractive errors.

      Note: For scleral lenses for masking irregular astigmatism, see section below. 

      Replacement lenses are considered medically necessary under medical plans if required because of a change in the patient's physical condition (not including refractive changes). Note: Charges to replace contact lenses that are lost, damaged, or required solely due to refractive changes are not covered under medical plans.

   4. Scleral Shell Contact Lenses

      Scleral shell contact lenses are considered medically necessary under medical plans for the following indications:

      1. For the treatment of keratoconjunctivitis sicca or "dry eye"; or
      2. When prescribed to support orbital tissue (such as where an eye has been rendered sightless and shrunken by inflammatory disease).

      Replacement lenses are considered medically necessary under medical plans if required because of a change in the member's physical condition (not including refractive changes). 

      Note: Charges to replace contact lenses that are lost, damaged, or required solely due to refractive changes are not covered under medical plans.

      Note: Scleral shell lenses are covered under plans that exclude coverage of contact lenses, as scleral shell lenses are not primarily for correction of refractive errors.

   5. Contact Lenses and Eyeglasses for Accidental Injury

      An initial pair of contact lenses or eyeglasses is considered medically necessary under medical plans when they are prescribed by a physician to correct a change in vision directly resulting from an accidental bodily injury.  Note: Charges to replace such contact lenses or eyeglasses are not covered under medical plans.

   6. Contact Lenses for Masking Irregular Astigmatism Associated with Keratoconus and Other Corneal Disorders

      Aetna considers services that are part of an evaluation of keratoconus or other corneal disorders associated with irregular astigmatism (e.g., keratoglobus, pellucid corneal degeneration, Terrien's marginal degeneration, post-LASIK ectasia, corneal scarring) medically necessary.  This includes the general examination, advanced corneal topographic modeling, and fitting of contact lenses or scleral lenses.

      Note: Most Aetna medical benefit plans exclude coverage of contact lenses and other vision aids.  Please check benefit plan descriptions for details.  These benefit plans do not cover contact lenses or scleral lenses for correcting astigmatism associated with keratoconus or other corneal disorders under medical plans that exclude coverage of contact lenses and eyeglasses.  This includes corneal contact lenses and scleral lenses that may be prescribed for masking irregular astigmatism associated with corneal ectasia (e.g., keratoconus, keratoglobus, pellucid corneal degeneration, Terriens marginal degeneration, post-LASIK ectasia), post-operative astigmatism (e.g., following refractive surgery or corneal transplant), corneal scarring (e.g., from trauma, infection, or Hydrops), and anterior corneal dystrophies (e.g. Meesman's, Cogan's).  Contact lenses and scleral lenses provided to members with keratoconus and other corneal disorders associated with irregular astigmatism are covered under the provisions of the member's vision care plan only.

   7. Contact Lenses for Myopia Management

      Aetna considers the following contact lenses for myopia management medically necessary when criteria are met. Note: Aetna standard medical benefit plans exclude coverage of vision aids, contact lenses and eyeglasses, and surgery to correct refractive errors; the following would be excluded from coverage under those plans. Please check benefit plan descriptions for details.
      

      1. Acuvue Abiliti Overnight Therapeutic Lenses 

         For correction of myopia in persons with myopia of up to 4 diopters (D) and no more than 1.5 D of astigmatism. 

      2. MiSight 1 Day Soft Contact Lenses 

         For correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment, are 8 to 12 years of age and have a refraction of -0.75 to -4.00 D (spherical equivalent) with less than or equal to 0.75 D of astigmatism.

   8. Echo Frames/Smart Audio Glasses

      Aetna considers Echo Frames/smart audio glasses not medically necessary.

   Note: Some HMO plans cover only an initial prosthetic, and exclude coverage of replacements of prosthetics regardless of medical necessity.  Under these plans, only an initial set of glasses or contact lenses are covered under the medical plan.  Please check benefit plan descriptions for details.

2. Experimental and Investigational

   The following procedures are considered experimental and investigational because the effectiveness of these approaches has not been established:

   1. Blue light filtering contact lenses for improvement of sleep, and use of electronic devices
   2. Corneal bandages for all other indications (except for the ones listed above)
   3. MiSight 1 Day Soft Contact Lenses for all other indications (except for the ones listed above)
   4. Orthokeratology lenses for correction of myopia and for all other indications (except for Acuvue Abiliti overnight therapeutic lenses; see above).

3. Policy Limitations and Exclusions

   Note: Many Aetna medical plans exclude coverage of contact lenses or eyeglasses.  Under medical plans with this exclusion, contact lenses are only covered under medical plans for a narrow set of therapeutic indications, as outlined below.  Additional coverage of contact lenses and eyeglasses may be provided under the member's vision care plan, if any.  Please check benefit plan descriptions for details.

4. Related Policies

   1. CPB 0023 - Corneal Remodeling
   2. CPB 0508 - Cataract Surgery

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Prosthetic Contact Lenses and Eyeglasses for Aphakia:
CPT codes covered if selection criteria are met:
92311	Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneal lens for aphakia, 1 eye
92312	corneal lens for aphakia, both eyes
92315	Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneal lens for aphakia, 1 eye
92316	corneal lens for aphakia, both eyes
92326	Replacement of contact lens
92352 - 92353	Fitting of spectacle prosthesis for aphakia
92358	Prosthesis service for aphakia, temporary (disposable or loan, including materials)
CPT codes not covered for indications listed in the CPB:
92371	Repair and refitting spectacles; spectacle prosthesis for aphakia
HCPCS codes covered if selection criteria are met:
S0592	Comprehensive contact lens evaluation
V2020	Frames, purchases
V2100 - V2499	Eyeglasses
V2500 – V2525, V2530 - V2599	Contact lens [except V2526]
V2630 - V2632	Intraocular lenses
V2782	Lens, index 1.54 to 1.65 plastic or 1.60 to 1.79 glass, excludes polycarbonate, per lens
V2783	Lens, index greater than or equal to 1.66 plastic or greater than or equal to 1.80 glass, excludes polycarbonate, per lens
V2784	Lens, polycarbonate or equal, any index, per lens
HCPCS codes not covered for indications listed in the CPB:
S0504	Single vision prescription lens (safety, athletic, or sunglass), per lens
S0506	Bifocal vision prescription lens (safety, athletic, or sunglass), per lens
S0508	Trifocal vision prescription lens (safety, athletic, or sunglass), per lens
S0510	Non-prescription lens (safety, athletic, or sunglass), per lens
S0514	Color contact lens, per lens
S0516	Safety eyeglass frames
S0518	Sunglasses frames
S0580	Polycarbonate lens (list this code in addition to the basic code for the lens)
S0581	Nonstandard lens (list this code in addition to the basic code for the lens)
S0590	Integral lens service, miscellaneous services reported separately
S0595	Dispensing new spectacle lenses for patient supplied frame
V2025	Deluxe frame
V2526	Contact lens, hydrophilic, spherical, photochromic additive, per lens
V2702	Deluxe lens feature
V2744	Tint, photochromatic, per lens
V2745	Addition to lens; tint, any color, solid, gradient or equal, excludes photochromatic, any lens material, per lens
V2750	Antireflective coating, per lens
V2756	Eye glass case
V2760	Scratch resistant coating, per lens
V2761	Mirror coating, any type, solid, gradient or equal, any lens material, per lens
V2762	Polarization, any lens material, per lens
V2780	Oversize lens, per lens
V2781	Progressive lens, per lens
V2786	Specialty occupational multifocal lens, per lens
ICD-10 codes covered if selection criteria are met:
H25.011 - H26.9	Cataract
H27.00 - H27.03	Aphakia
Q12.0	Congenital cataract
Q12.3	Congenital aphakia
Z96.1	Presence of intraocular lens
Z98.41 - Z98.49	Cataract extraction status
Therapeutic Hydrophilic Contact Lenses (Corneal Bandage):
CPT codes covered if selection criteria are met:
92071	Fitting of contact lens for treatment of ocular surface disease
92072	Fitting of contact lens for management of keratoconus, initial fitting
HCPCS codes covered if selection criteria are met:
S0515	Scleral lens, liquid bandage device, per lens
V2520 - V2523	Contact lens, hydrophilic
V2530	Contact lens, scleral, gas impermeable, per lens
V2531	Contact lens, scleral, gas permeable, per lens
ICD-10 codes covered if selection criteria are met:
B02.30 - B02.39	Zoster ocular disease
D89.811	Chronic graft-versus-host disease
G90.1	Familial dysautonomia [Riley-Day]
H02.881 - H02.888	Meibomian gland dysfunction of eyelid
H04.121 - H04.129	Dry eye syndrome of lacrimal gland
H16.211 - H16.219	Exposure keratoconjunctivitis
H16.221 - H16.229	Keratoconjunctivitis sicca, not specified as Sjogren's
H16.231 - H16.239	Neutrophic keratoconjunctivitis
H18.811 - H18.819	Anesthesia and hypoesthesia of cornea
L12.1	Cicatricial pemphigoid
L20.0 - L20.9	Atopic dermatitis
L51.1	Stevens-Johnson syndrome
L51.2	Toxic epidermal necrolysis [Lyell]
L51.3	Stevens-Johnson syndrome-toxic epidermal necrolysis overlap syndrome
M05.00 - M06.9	Rheumatoid arthritis
M35.00 - M35.09	Sicca syndrome
Q13.1	Absence of iris
Q81.0 - Q81.9	Epidermolysis bullosa
Q82.4	Ectodermal dysplasia (anhidrotic)
Q87.89	Other specified congenital malformation syndromes, not elsewhere classified [Seckle's syndrome]
T26.00XA – T26.92XS	Burn and corrosion confined to eye and adnexa
T66.XXXA – T66.XXXS	Radiation sickness, unspecified [dry eyes due to radiation]
Scleral Shell Contact Lenses:
CPT codes covered if selection criteria are met:
92313	Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneoscleral lens
92317	Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneoscleral lens
HCPCS codes covered if selection criteria are met:
V2627	Scleral cover shell
ICD-10 codes covered if selection criteria are met:
H04.121 - H04.129	Dry eye syndrome of lacrimal gland
H05.10	Unspecified chronic inflammatory disorders of orbit
H05.30 - H05.359	Deformity of orbit
H16.221 - H16.229	Keratoconjunctivitis sicca, not specified as Sjogren's
M35.00 - M35.09	Sicca syndrome [Sjogren's disease]
Contact Lenses and Eyeglasses for Accidental Injury:
CPT codes covered if selection criteria are met:
92310	Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneal lens, both eyes, except for aphakia [initial]
92314	Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneal lens, both eyes except for aphakia [initial]
CPT codes not covered for indications listed in the CPB:
92326	Replacement of contact lens
ICD-10 codes covered if selection criteria are met:
H44.601 - H44.799	Retained (old) intraocular foreign body
S00.10XA – S00.12XS	Contusion of eyelid and periocular area
S00.201A – S00.279S	Superficial injuries of eyelid and periocular area
S01.101A – S01.159S	Open wound of eyelid and periocular area
T15.00XA – T15.92XS	Foreign body on external eye
Z87.821	Personal history of retained foreign body fully removed
Numerous options	Burn of eye, face, head, and neck, sequela [Codes not listed due to expanded specificity]
Numerous options	Open wound of head, neck, and trunk, sequela [Codes not listed due to expanded specificity]
Contact Lenses for Masking Irregular Astigmatism Associated with Keratoconus and Other Corneal Disorders:
CPT codes covered if selection criteria are met:
92025	Computerized corneal topography, unilateral or bilateral, with interpretation and report
92071	Fitting of contact lens for treatment of ocular surface disease
92072	Fitting of contact lens for management of keratoconus, initial fitting
HCPCS codes covered if selection criteria are met:
S0592	Comprehensive contact lens evaluation
V2500 – V2513	Contact lens
ICD-10 codes covered if selection criteria are met:
H17.00 - H17.9	Corneal scars and opacities
H18.40 - H18.9	Corneal degeneration
H18.601 - H18.629	Keratoconus
H18.711 - H18.719	Corneal ectasia [post-LASIK]
Q13.4	Other congenital corneal malformations
Q15.0	Congenital glaucoma [keratoglobus]
Contacts for Myopia Management:
CPT codes covered if selection criteria are met:
92310	Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneal lens, both eyes, except for aphakia [initial]
92314	Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneal lens, both eyes except for aphakia [initial]
HCPCS codes covered if selection criteria are met:
Acuvue Abiliti Overnight Therapeutic Lenses -no specific code
S0592	Comprehensive contact lens evaluation
V2525	Contact lens, hydrophilis, dual focus, per lens [MiSight 1 Day]
ICD-10 codes covered if selection criteria are met::
H52.10 – H52.13	Myopia
Echo Frames/smart audio glasses:
HCPCS codes not covered for indications listed in the CPB:
Echo Frames/smart audio glasses – no specific code

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Background

Therapeutic soft hydrophilic contact lenses are made of poly-2-hydroxyethyl methacrylate and other flexible plastics. They are about 13 to 15 mm in diameter and cover the entire cornea. Hydrophilic contact lenses may be prescribed for the treatment of bullous keratopathy and other corneal disorders (bandage lenses). Prophylactic antibiotic eye-drops may be used with a bandage lens. Most therapeutic eye-drops can be used with hydrophilic lenses.

The Boston Scleral Lens is a fluid-ventilated scleral lens designed to enclose aqueous fluid over the corneal surface. The scleral lens acts as a corneal bandage, and can mask irregular astigmatism.  The scleral lens rests entirely on the sclera and avoids all contact with the cornea.  Thus, the scleral lens can be used by persons who are intolerant to standard (hard) contact lenses, which rest on the sensitive cornea. The Boston Scleral lens has a series of channels that aspirate tears into the fluid reservoir while preventing the formation of air bubbles in the reservoir.

Scleral shell (or shield) is a catchall term for different types of hard scleral contact lenses. A scleral shell fits over the entire exposed surface of the eye as opposed to a corneal contact lens that covers only the central nonwhite area encompassing the pupil and iris.

When an eye has been rendered sightless and shrunken by inflammatory disease, a scleral shell may, among other things, obviate the need for surgical enucleation and prosthetic implant and act to support the surrounding tissue. In such a case, the device serves essentially as an artificial eye.

Scleral shells are occasionally used in connection with artificial tears in the treatment of "dry eye" of diverse etiology. Tears ordinarily dry at a rapid rate, and are continually replaced by the lacrimal gland. When the lacrimal gland fails, the half-life of artificial tears may be greatly prolonged by the use of the scleral shell contact lens as a protective barrier against the drying action of the atmosphere. Thus, the difficult and sometimes hazardous process of frequent instillation of artificial tears may be avoided. The lens acts in this instance to substitute, in part, for the functioning of the diseased lacrimal glands and would be considered a prosthetic device in the rare case when it is used in the treatment of dry eye.

Aphakic Contact Lenses for Infants with Aphakia

Lambert and colleagues (2014) conducted the Infant Aphakia Treatment Study, a multi-center, randomized clinical trial (RCT), comparing the visual outcomes of patients optically corrected with contact lenses versus intraocular lens (IOL) implantation following unilateral cataract surgery in early infancy. This RCT consisted of 114 infants with unilateral congenital cataracts with 5 years of follow-up and visual acuity assessment at 4.5 years of age. The median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups (both, 0.90 (20/159); p=0.54). About 50% of treated eyes in both groups had visual acuity ≤20/200. Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery (contact lens, 56%; IOL, 81%; p=.016). The most common adverse events in the IOL group included lens reproliferation into the visual axis, pupillary membranes and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs. 28% of eyes in the IOL group (p=.55). Since the initial cataract surgery, significantly more patients in the IOL group have had at least 1 additional intraocular surgery (contact lens, 21%; IOL, 72%; p<.0001). No significant difference was observed between the medial visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic. However, the IOL group had significantly more adverse events and additional intraoperative procedures. The investigators recommended leaving the eye aphakic and focusing the eye with a contact lens when operating on an infant with a unilateral cataract < 7 months of age. Furthermore, primary IOL implantation should be reserved for infants the surgeon believes that the burden of cost and handling of a contact lens may result in significant periods of uncorrected aphakia.

VanderVeen and colleagues (2021) reported outcomes of secondary intraocular lens (IOL) implantation in the Infant Aphakia Treatment Study (IATS), a multicenter, randomized clinical trial. The investigators evaluated visual outcomes, refractive outcomes, and adverse events at age 10 1/2 years. Eyes that remained aphakic eyes were compared to eyes randomized to primary IOL placement. Fifty-five out of fifty-seven patients randomized to aphakia with contact lens correction were seen for the 10 ½ year study visit; 24/55 eyes (44%) had secondary IOL surgery. Median age at IOL surgery was 5.4 years (range 1.7 to 10.3 years). Mean absolute prediction error was 1.0 ± 0.7D. At age 10 ½ years, the median log MAR VA was 0.9 (range 0.2 to 1.7), similar to VA in the 31 eyes still aphakic (0.8, range 0.1 to 2.9); the number of eyes with stable or improved VA scores between the 4 ½ and 10 ½ year study visits was also similar (78% secondary IOL eyes, 84% aphakic eyes). For eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age 10 ½ years was −3.2 ±2.7D (range −9.9D to 1.1D), compared to −5.5 ±6.6 D (n=53, range −26.5 to 3.0D) in eyes with primary IOL (p=0.03). The investigators concluded that delayed IOL implantation provides a more predictable refractive outcome at age 10 1/2 years, though the range of refractive error is still large.

Contact Lenses for Myopia Management

Acuvue Abiliti Overnight Therapeutic Lenses

Acuvue Abiliti Overnight Therapeutic Lenses (Johnson & Johnson Vision Care, Inc) were U.S. FDA-approved in May 2021 for the management of nearsightedness (myopia) in non-diseased eyes when prescribed and managed by a qualified eye professional. The lenses are indicated for overnight wear for the temporary reduction of myopia up to 4.00 diopters (D) with eyes having astigmatism up to 1.50 D, and subject to the eye care professional’s myopia management plan, may eliminate the need to wear contact lenses or glasses throughout the waking hours after lenses are removed. The lenses are manufactured from Menicon Z (tisilfocon A) (Johnson & Johnson, 2021a).

Acuvue Abiliti Overnight are orthokeratology (ortho-k) contact lenses that are specifically designed and fitted to match a patient’s eye based on its unique corneal shape to temporarily reshape the cornea during sleep with the goal of correcting myopia during the day without correction. The lenses produce a temporary reduction of myopia by changing the shape (flattening) of the cornea. Flattening the cornea reduces the focusing power of the eye, and if the amount of corneal flattening is properly controlled, it is possible to bring the eye into correct focus and completely compensate for myopia. Thus, these lenses are designed to purposely flatten the shape of the cornea by applying slight pressure to the center of the cornea when the patient is asleep. After the lens is removed, the cornea retains its altered shape for all or part of the remainder of the day. The lenses are to be worn overnight with removal during the following day. The lenses must be worn at night on a regular schedule to maintain the orthokeratology effect, or the myopia will revert to the pre-treatment level (Johnson & Johnson, 2021a, 2021b). 

Acuvue Abiliti Overnight lenses are optimized by the use of corneal topography, refractive error and other measurements connected to an experiential fitting software, FitAbiliti. The FitAbiliti software guides the eye care professional through the fitting process and recommends a lens. Abiliti Overnight lenses will be available in two different contact lens designs: Acuvue Abiliti Overnight Therapeutic Lenses for Myopia Management, and Acuvue Abiliti Overnight Therapeutic Lenses for Myopia Management for Astigmatism (Johnson & Johnson, 2021b).

FDA approval was based on a study that evaluated a total of 300 eyes (150 patients) with 274 eyes (137 patients) completing a minimum of 12 months of contact lens wear. Data on 252 eyes were analyzed after 12 months of wear. A total of 251 eyes showed some reduction in myopic refractive error. The average reduction was -2.48 diopters with a range from -0.25 to -4.00 diopters. The amount of myopia reduction varied between patients and could not be predicted prior to treatment. The Acuvue Abiliti Overnight provided a temporary full reduction in some patients with up to -4.00 diopters of myopia. A total of 185 (73%) eyes achieved a visual acuity of 20/20 or better and 242 (96%) eyes achieved 20/40 or better. For the 252 eyes analyzed after 12 months of wear, 55% had no change in or improved best spectacle-corrected visual acuity (BSCVA), while 38% had a loss of 1 line in BSCVA compared to baseline. Four eyes (2 patients) showed a constant reduction of greater than or equal to 2 lines of BSCVA from initial visit to 12-month visit. Reasons of the vision loss were not accurately determined in these cases; however, no significant ocular abnormalities were observed in these eyes at the time of study exit. Of the 252 eyes with initial cylinder power ranging from 0 to 1.50 D, changes in astigmatism after 12 months of wear found decrease from 0.25 to 0.50 D on 85 eyes (34%); decrease from 0.75 to 1.00 D on 71 (28%) of eyes; and decrease greater than or equal to 1.25 D on 14 (6%) of eyes. No astigmatism change was found in 81 (32%) of eyes (Johnson & Johnson, 2021a).

Labeled contraindications include the following:

• Acute and sub-acute inflammation or infection of the anterior chamber of the eye
• Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids
• Dry eyes
• Reduced corneal sensitivity
• Any systemic disease which may affect the eye or be exacerbated by wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa which may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
• Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care for the Acuvue Abiliti Overnight
• Any active corneal infection (bacterial, fungal or viral)
• If eyes are red or irritated.

Per the label, it is not expected that the lenses will provide a risk that is greater than other overnight wear rigid gas permeable contact lenses. The most common side effects which occur in general rigid contact lens wearers are corneal edema and corneal staining. It is anticipated that these two side effects can also occur in some wearers of Acuvue Abiliti Overnight. Other side effects, which may occur, include pain, redness, tearing, irritation, discharge, or abrasion of the eye. When overnight orthokeratology lenses dislocate during sleep, transient distorted vision may occur the following morning after removal of the lenses. This distortion may not be corrected with spectacle lenses. The duration of the distorted vision would rarely be greater than the duration of the daily visual improvement normally achieved with the lenses (Johnson & Johnson, 2021a).

MiSight 1 Day Soft Contact Lenses

MiSight 1 Day soft contact lenses for daily wear (Cooper Vision, Inc.) were FDA-approved in 2019 for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8 to 12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The MiSight soft contact lenses are meant to be worn daily to correct nearsightedness and slow the progression of myopia in children with healthy eyes. When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia. MiSight contact lenses are made from a material containing 60% water and 40% omafilcon A. They are intended for single use, are disposable, and should be discarded at the end of each day, not worn overnight (FDA, 2019).

FDA approval was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. The safety and effectiveness of MiSight was studied in a three-year randomized, controlled clinical trial by Chamberlain et al (2019) which showed that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup. Over the course of the trial, there were no serious ocular adverse events in either arm of the study. Additionally, to estimate the rate of vision-threatening corneal infections (i.e., corneal ulcers) among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eye care clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily (FDA, 2019).

Chamberlain et al (2019) conducted a 3-year parallel-group, randomized, controlled, double-masked clinical trial to evaluate the effectiveness of the MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. One-hundred-forty-four (144) myopic children (spherical equivalent refraction, -0.75 to -4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in this multicenter study. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction (SERE) and axial length. Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was -0.73 D (59%) less in the test group than in the control group (p < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (p < .001). Changes in SERE and axial length were highly correlated (r = -0.90, p < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. The authors concluded that the results demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length. 

Chalmers et al (2021) conducted a retrospective cohort review (ReCSS study) to estimate a rate of microbial keratitis and other adverse events in conventional daily wear soft contact lenses (SCL) in children initially fit between the ages of 8-12 years of age, ascertaining the safety of SCL wear in children in real-world clinical practice settings. The study reviewed clinical charts from 963 children: 782 patients in 7 US eye care clinics and 181 subjects from 2 international randomized clinical trials. Subjects were first fitted while 8 to 12 years old with various SCL designs, prescriptions and replacement schedules, and observed through to age 16. Clinical records from visits with potential adverse events (AEs) were electronically scanned and reviewed to consensus by an Adjudication Panel. The study encompassed 2713 years‐of‐wear and 4611 contact lens visits. The cohort was 46% male, 60% were first fitted with daily disposable SCLs, the average age at first fitting was 10.5 years old, with a mean of 2.8 ± 1.5 years‐of‐wear of follow‐up observed. There were 122 potential ocular AEs observed from 118/963 (12.2%) subjects; the annualized rate of non‐infectious inflammatory AEs was 0.66%/year (95% CI 0.39–1.05) and 0.48%/year (0.25–0.82) for contact lens papillary conjunctivitis. After adjudication, two presumed or probable microbial keratitis (MK) cases were identified, a rate of 7.4/10 000 years‐of‐wear (95% CI 1.8–29.6). Both were in teenage boys and one resulted in a small scar without loss of visual acuity. The authors concluded that this estimated the MK rate and the rate of other inflammatory AEs in a cohort of SCL wearers from 8 through to 16 years of age. Both rates are comparable to established rates among adults wearing SCLs.

Each lens is supplied sterile in a blister containing buffered isotonic saline solution. For best results, it is recommended that the patient wears the lens for a minimum of 10 hours per day for at least 6 days per week. Daily wear lenses are not indicated for overnight wear, and patients should be instructed not to wear lenses while sleeping.

PVR-PROSE Scleral Lens

PVR PROSE Treatment uses prosthetic lenses that are large-diameter gas permeable contact lenses, specially designed to vault over the entire corneal surface and rest on the "white" of the eye.  In doing so, PVR PROSE lenses functionally replace the irregular cornea with a perfectly smooth optical surface to correct vision problems caused by keratoconus, Lasik failures, post-surgical complications, and other corneal irregularities.  PVR PROSE lenses are designed to vault the corneal surface and rest on the less sensitive surface of the sclera, these lenses often are more comfortable for a person with corneal irregularities, like keratoconus.  A special liquid fills the space between the back surface of the lens and the front surface of the cornea.  This liquid acts as a buffer and protects the compromised corneal tissue.

Echo Frames/Smart Audio Glasses

Echo Frames are smart audio glasses that provide hands-free access to Alexa.  Customers can listen to audio entertainment, control their smart home, stay productive and organized, and communicate hands-free.  Echo Frames launched in 2019, are available in the U.S. only, and have over 5,300 customer reviews with a 4.2 out of 5-star rating.  Echo Frames are lightweight, IPX4 splash-resistant for water and sweat and are available in prescription ready frames, polarized sunglass lenses with UV400 protection or blue light filtering lenses.  However, there is a lack of evidence that the use of Echo Frames / smart audio glasses would improve health outcomes.

Mulfari et al (2017) noted that in the field of deep learning, this study presented the design of a wearable computer vision system for visually impaired users.  The Assistive Technology solution exploits a powerful single-board computer and smart glasses with a camera in order to allow its user to examine objects within his/her surrounding environment, while it employs Google TensorFlow machine learning framework in order to real time classify the acquired stills.  The authors concluded that the proposed aid could enhance the awareness of the explored environment and it interacted with its user by means of audio messages.

Caria et al (2019) stated that the growing interest in augmented reality (AR) systems is becoming increasingly evident in all production sectors.  However, to the authors' knowledge, a literature gap has been found with regard to the application of smart glasses for AR in the agriculture and livestock sector.  In fact, this technology allows farmers to manage animal husbandry in line with precision agriculture principles.  These researchers examined the performances of an AR head-wearable device as a valuable and integrative tool in precision livestock farming.  In this study, the GlassUp F4 Smart Glasses (F4SG) for AR were examined.  Laboratory and farm tests were carried out to examine the implementation of this new technology in livestock farms.  The results highlighted several advantages of F4SG applications in farm activities.  The clear and fast readability of the information related to a single issue, combined with the large number of readings that SG performed, allowed F4SG adoption even in large farms.  Furthermore, the 7 hours of battery life and the good quality of audio-video features highlighted their valuable attitude in remote assistance, supporting farmers on the field.  Nevertheless, other studies are needed to provide more findings for future development of software applications specifically designed for agricultural purposes.

Yoon et al (2021) noted that observation of medical trainees' care performance by experts can be extremely helpful for ensuring safety and providing quality care.  The advanced technology of smart glasses enables health professionals to video stream their operations to remote supporters for collaboration and cooperation.  This study monitored the clinical situation by using smart glasses for remote co-operative training via video streaming and clinical decision-making via simulation based on a scenario of emergency nursing care for patients with arrhythmia.  The clinical operations of bedside trainees, who is Google Glass Enterprise Edition 2 (Glass EE2) wearers, were live streamed via their Google Glasses, which were viewed at a remote site by remote supporters via a desktop computer.  Data were obtained from 31 nursing students using 8 essay questions regarding their experience as desktop-side remote supporters.  Most of the participants reported feeling uneasy regarding identifying clinical situations (84 %), patients' condition (72 %), and trainees' performance (69 %).  The current system demonstrated sufficient performance with a satisfactory level of image quality and auditory communication, while network and connectivity were areas that require further improvement.  The reported barriers to identifying situations on the remote desktop were predominantly a narrow field of view and motion blur in videos captured by Glass EE2s; and using the customized mirror mode.  The authors concluded that the current commercial Glass EE2 could facilitate enriched communication between remotely located supporters and trainees by sharing live videos and audio during clinical operations.  Moreover, these researchers stated that further improvement of hardware and software user interfaces are needed to ensure better applicability of smart glasses and video streaming functions to clinical practice settings.

Blue Light Filtering Contact Lenses

In a prospective, longitudinal, pilot study, Sanchez-Gonzalez et al (2021) examined the effect of contact lenses with blue light filters on contrast sensitivity and any alteration in tear quantity and quality.  This trial entailed 3 visits by each subject.  Monocular visual acuity (VA), contrast sensitivity (CS), phenol red thread test, and tear breakup time (TBUT) were measured at each visit.  There were significant differences in logarithmic CS between the groups.  The TBUT was significantly lower after using video display terminals than before (p < 0.05).  No differences in TBUT were observed between groups video display terminals and contact lenses having the blue filter (p > 0.05); however, higher mean values were observed in the group after video display terminal use with contact lenses having the blue filter than that with standard contact lenses (p > 0.05 in both groups).  In addition, the mean value of phenol red thread test on the group after video display terminal use with contact lenses having the blue filter was lower than the group before its use (p > 0.05).  The authors concluded that the findings of this study established a possible relationship between tear stability, improved CS, and the use of a blue filter in contact lenses.  These preliminary findings from a pilot study need to be validated by well-designed studies.

Furthermore ,the American Academy of Ophthalmology (AAO, 2023) noted that eyeglasses that claim to filter out blue light from computers, smartphones, and tablets are becoming increasingly popular.  Advertisements for these glasses claim that over-exposure to blue light can lead to various problems, including digital eye strain, sleep cycle disruption, or even blinding eye diseases; however, there is a lack of evidence that the blue light from screen of electronic devices is damaging to the eyes.  The AAO does not recommend any special eye-wear for computer use. 

An UpToDate review on “What's new in sleep medicine” (Eichler et al, 2023) states that “Lack of evidence that blue light-filtering lenses improve sleep -- Blue light-filtering glasses are marketed widely to reduce adverse effects of light-emitting screens on sleep, but supporting evidence is lacking.  A recent systematic review identified six small, randomized trials examining sleep outcomes with use of blue light-filtering lenses.  Trial results were inconsistent, and meta-analysis could not be performed due to high heterogeneity and lack of quantitative outcome data.  We counsel patients to avoid use of electronics at least 30 minutes before usual bedtime and in the middle of the night if nocturnal awakenings occur.  Based on available evidence, we advise that blue light-filtering glasses are not a substitute for avoidance of screens”.

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References