100 Participants Needed

Wavefront Guided Scleral Lenses for Keratoconus and Astigmatism

(WFG Sclerals Trial)

BF
SL
Overseen ByStacey Lazar, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cornea and Laser Eye Institute

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.12345

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.678910

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.1241112

Research Team

JD

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.
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cornea and Laser Eye Institute

Lead Sponsor

Trials
10
Recruited
1,100+

References

Wavefront-guided scleral lens prosthetic device for keratoconus. [2022]
Ocular Impression-Based Scleral Lens With Wavefront-Guided Optics for Visual Improvement in Keratoconus. [2023]
Scleral Lenses Reduce the Need for Corneal Transplants in Severe Keratoconus. [2017]
[Quality of life in patients wearing scleral lenses]. [2022]
Quality-of-Life Improvement After Scleral Lens Fitting in Patients With Keratoconus. [2023]
[Comparison of retaining or removing negative vertical coma in wavefront guided LASIK for myopia and astigmatism]. [2008]
Wavefront-guided customized corneal ablation. [2022]
Wavefront-guided LASIK for the correction of primary myopia and astigmatism a report by the American Academy of Ophthalmology. [2022]
LASIK for hyperopia with the WaveLight excimer laser. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Bilateral implantation of a supplementary intraocular pinhole. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
The Outcome of Scleral Lens Fitting for Keratoconus With Resolved Corneal Hydrops. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Wavefront-guided scleral lens correction in keratoconus. [2022]