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

N/A
Recruiting
Led By John D Gelles, OD
Research Sponsored by Cornea and Laser Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
-A diagnosis of keratoconus or irregular astigmatism
A diagnosis of keratoconus or irregular astigmatism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

WFG Sclerals Trial Summary

This trial is testing a new type of contact lens that may help improve vision for people with certain eye conditions.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the trial doesn't explicitly mention side effects, wearing scleral lenses typically can cause discomfort, redness, dry eyes or potential infection if not used properly.

WFG Sclerals Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with keratoconus or irregular astigmatism.
Select...
I have been diagnosed with keratoconus or irregular astigmatism.

WFG Sclerals Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Higher order aberration
Secondary outcome measures
Contrast Sensitivity
Visual Acuity

WFG Sclerals Trial Design

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 Location

Who is running the clinical trial?

Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
1,013 Total Patients Enrolled
John D Gelles, ODPrincipal InvestigatorThe Cornea and Laser Eye Institute

Media Library

Wavefront Guided Scleral Lenses Clinical Trial Eligibility Overview. Trial Name: NCT04698590 — N/A
Corneal Wavefront Aberration Research Study Groups: WFG Scleral Lenses, Traditional Scleral Lenses
Corneal Wavefront Aberration Clinical Trial 2023: Wavefront Guided Scleral Lenses Highlights & Side Effects. Trial Name: NCT04698590 — N/A
Wavefront Guided Scleral Lenses 2023 Treatment Timeline for Medical Study. Trial Name: NCT04698590 — N/A
Corneal Wavefront Aberration Patient Testimony for trial: Trial Name: NCT04698590 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are signing up to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov indicates that this clinical study, which was initially made available on January 15th 2021, is still looking for participants. Presently, 100 individuals are required at a single medical centre."

Answered by AI

Are there any existing opportunities for individuals to participate in this experiment?

"Yes, according to the published details on clinicaltrials.gov this trial is seeking participants; it was first made available on January 15th 2021 and updated most recently in April 14th 2021. The project aims to recruit a total of 100 patients from one site."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Cornea and Laser Eye Institue - Hersh Vision Group
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My already limited contact lens options have recently been limited even further due to a discontinuation of my longstanding brand in my Rx.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Cornea and Laser Eye Institue - Hersh Vision Group: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism
2021. "Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04698590.
All > Intraocular Lens > Keratoconus
~24 spots leftby Apr 2025
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