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

Overseen ByStacey Lazar, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cornea and Laser Eye Institute

Disqualifiers: Other ocular pathology, others

Trial Summary

What is the purpose of this trial?

This trial is testing special contact lenses for people with severe vision issues that regular lenses can't fix. These custom-made lenses use advanced eye measurements to improve vision quality by correcting specific distortions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Wavefront Guided Scleral Lenses for Keratoconus and Astigmatism?

Research shows that wavefront-guided scleral lenses can significantly improve vision in patients with keratoconus by reducing visual distortions and enhancing visual clarity. In one case, these lenses improved visual acuity by two lines on an eye chart, demonstrating their potential to help people see better.¹ ² ³ ⁴ ⁵

Is there safety data for wavefront guided treatments?

The research on wavefront guided LASIK, which is a similar technology, shows that it is generally safe for treating myopia (nearsightedness) and astigmatism (a condition where the eye does not focus light evenly on the retina). This suggests that wavefront guided treatments, like scleral lenses, may also be safe, but specific safety data for scleral lenses is not provided in the available research.⁶ ⁷ ⁸ ⁹ ¹⁰

How is the treatment Wavefront Guided Scleral Lenses unique for keratoconus and astigmatism?

Wavefront Guided Scleral Lenses are unique because they use advanced optics to correct higher order aberrations (imperfections in the eye's optical system) in keratoconus, improving visual quality more effectively than traditional lenses. This treatment involves custom-fitting lenses based on detailed eye measurements, which can significantly enhance vision clarity for patients who have not benefited from standard scleral lenses.¹ ² ⁴ ¹¹ ¹²

Research Team

John D Gelles, OD

Principal Investigator

The Cornea and Laser Eye Institute

Eligibility Criteria

This trial is for individuals with keratoconus or irregular astigmatism, which are conditions that distort vision. Participants must be able to apply and remove scleral lenses themselves and should not have other major eye diseases affecting their sight.

Inclusion Criteria

I have been diagnosed with keratoconus or irregular astigmatism.

Exclusion Criteria

I have an eye condition that significantly affects my vision.

I cannot put in or take out a scleral lens by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditional scleral lenses or wavefront guided scleral lenses to evaluate vision improvement

4 weeks

1 visit (in-person) for lens fitting and dispensing

Follow-up

Participants are monitored for changes in higher order aberrations, visual acuity, and contrast sensitivity

4 weeks

1 visit (in-person) for follow-up evaluation

Treatment Details

Interventions

Wavefront Guided Scleral Lenses

Trial OverviewThe study is comparing two types of contact lenses: Wavefront Guided Scleral Lenses designed to correct specific visual aberrations, versus Traditional Scleral Lenses that help improve vision but may not address all issues caused by higher order aberrations.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: WFG Scleral LensesActive Control1 Intervention

Scleral lenses with customized wavefront guided optics

Group II: Traditional Scleral LensesPlacebo Group1 Intervention

Scleral lenses with traditional optics