Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism (WFG Sclerals)

Cornea and Laser Eye Institute

Status: Active, not recruiting

Conditions: Keratoconus; Irregular Astigmatism; Aberration, Corneal Wavefront; Pellucid Marginal Corneal Degeneration; Keratoglobus; Corneal Ectasia; Wavefront Aberration, Corneal

Treatments: Device: Traditional Scleral Lenses; Device: Wavefront Guided Scleral Lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT04698590

CLEI WFG Scleral Lens

Details and patient eligibility

About

Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (HOA). HOA's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. Specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing HOA's and improving vision. In many patients the resultant vision, though improved, still has some level of residual HOA's affecting the quality of vision. Custom scleral lenses with customized wavefront guided optics can be used to reduce residual HOA's and improve vision further. These lenses have been referred to as higher order aberration correcting scleral lenses or HOA correcting sclerals and wavefront guided scleral lenses or WFG sclerals.

Full description

The purpose of this study is to investigate the effect of an advanced technique for designing custom scleral contact lenses to further improve vision in keratoconus or irregular astigmatism by reducing residual aberrations. The derived custom scleral lenses will include customized aberration correcting optics, guided by a wavefront aberrometer measurements. These lenses are custom made based on the individual measurements from an eye.The primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. In particular, the investigators will compare efficacy in reducing aberrations and improvement in vision.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-A diagnosis of keratoconus or irregular astigmatism

Exclusion criteria

• Patients with other visually significant ocular pathology.
• Inability to apply or remove a scleral lens.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

WFG Scleral Lenses

Active Comparator group

Description:

Scleral lenses with customized wavefront guided optics

Treatment:

Device: Wavefront Guided Scleral Lenses

Traditional Scleral Lenses

Placebo Comparator group

Description:

Scleral lenses with traditional optics

Treatment:

Device: Traditional Scleral Lenses

Sponsor of this trial

Lead Sponsor

Cornea and Laser Eye Institute