Wavefront Guided Scleral Lenses for Keratoconus and Astigmatism

(WFG Sclerals Trial)

Overseen By John D Gelles, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cornea and Laser Eye Institute

Disqualifiers: Other ocular pathology, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests special contact lenses called Wavefront Guided Scleral Lenses. These lenses aim to improve vision for individuals with keratoconus or irregular astigmatism, conditions that cause blurry or distorted vision. The study compares these new lenses to traditional scleral lenses to determine which better corrects vision issues. Individuals who struggle to see clearly with regular glasses or contacts and have been diagnosed with keratoconus or irregular astigmatism might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative vision correction options.

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 prior data suggests that these wavefront guided scleral lenses are safe for correcting vision in keratoconus and astigmatism?

Research shows that wavefront guided scleral lenses are safe. Studies have found that people with keratoconus, a condition where the cornea becomes thin and cone-shaped, generally tolerate these lenses well. Evidence suggests that these lenses effectively improve vision and are safe to use.

The technology behind these lenses resembles wavefront guided LASIK, a safe procedure for correcting nearsightedness and astigmatism. This similarity supports confidence in the lenses' safety.

In summary, current data supports the safety of wavefront guided scleral lenses, with most users experiencing few problems. However, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Wavefront Guided Scleral Lenses are unique because they use customized wavefront-guided optics, which aim to provide a more tailored vision correction by accounting for each individual's specific vision distortions. Traditional treatments for keratoconus and astigmatism, like regular scleral lenses or glasses, primarily focus on simple refractive errors and may not address higher-order aberrations effectively. Researchers are excited about this treatment because it has the potential to offer clearer and sharper vision by targeting those complex vision issues, which standard lenses often miss. This innovative approach could significantly improve visual acuity and quality of life for patients with these challenging eye conditions.

What evidence suggests that wavefront guided scleral lenses are effective for keratoconus and astigmatism?

Research has shown that wavefront-guided scleral lenses, which participants in this trial may receive, effectively help with eye conditions like keratoconus. These special lenses reduce visual problems such as halos or glare that regular lenses cannot fix. One study found that these lenses improve vision by addressing these issues more effectively than traditional lenses. Specifically, individuals with keratoconus reported significant improvements in their vision quality with these lenses. Overall, these lenses offer a promising option for those with vision problems that regular glasses or contacts cannot correct. ^{1 3 6 7 8}

Who Is on the Research Team?

John D Gelles, OD

Principal Investigator

The Cornea and Laser Eye Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Wavefront Guided Scleral Lenses

Trial Overview The 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.

How Is the Trial Designed?

Group I: WFG Scleral Lenses Active Control 1 Intervention

Scleral lenses with customized wavefront guided optics

Group II: Traditional Scleral Lenses Placebo Group 1 Intervention

Scleral lenses with traditional optics

Who Is Running the Clinical Trial?

Cornea and Laser Eye Institute

Lead Sponsor

Trials

10

Recruited

1,100+

Citations

1. vision-institute.com vision-institute.com/wavefront-guided-scleral-lenses-and-clei-a-new-frontier-in-vision-correction/

Wavefront-Guided Scleral Lenses & CLEI Wavefront-guided scleral lenses are effective in managing a range of corneal conditions and complications, including: Keratoconus: Providing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04698590

Wavefront Guided Scleral Lenses for Keratoconus and ... The primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. In ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4232493/

Wavefront-Guided Scleral Lens Correction in Keratoconus To examine the performance of state-of-the-art wavefront-guided scleral contact lenses (wfgSCLs) on a sample of keratoconic eyes, with emphasis on ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41159562/?utm_source=Firefox&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1bexwgOHj9hYdy18j9a2EiweBaLO2gt9aSm4u5vU2gDVhezYjC&fc=20240423212827&ff=20251102102816&v=2.18.0.post22+67771e2

Impact of contact lens correction on wavefront aberrations ... This review examines the optical characteristics of the cornea in keratoconus, including the induction of elevated ocular wavefront errors.

5. mdpi.com mdpi.com/2075-4426/14/10/1051

Impact of Scleral Lenses on Visual Acuity and Ocular ... This review evaluates the efficacy of SLs in enhancing VA and reducing aberrations in patients with corneal ectasia.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11509004/

Impact of Scleral Lenses on Visual Acuity and Ocular ... This review evaluates the efficacy of SLs in enhancing VA and reducing aberrations in patients with corneal ectasia.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7547898/

Safety and Efficacy of Scleral Lenses for Keratoconus - PMC Our study demonstrates excellent safety and efficacy of scleral contact lenses in subjects with keratoconus.

8. withpower.com withpower.com/trial/phase-corneal-wavefront-aberration-2021-adfde

Wavefront Guided Scleral Lenses for Keratoconus and ... The research on wavefront guided LASIK, which is a similar technology, shows that it is generally safe for treating myopia (nearsightedness) and astigmatism ...