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Contact Lens

Corneal Gas Permeable Lenses for Keratoconus

N/A

Recruiting

Led By Ellen S Shorter, OD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of keratoconus

Be older than 18 years old

Must not have

No prior corneal transplantation or INTACTS

Presence of corneal scarring

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, study visit 1 (2-4 weeks), study visit 2 (4-10 weeks) and at study completion (6-24 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two methods of correcting vision for people with keratoconus, a condition where the shape of the cornea becomes irregular. The study will compare how well each method works and how satisfied patients are with their vision.

Who is the study for?

This trial is for individuals with mild to moderate keratoconus, a condition where the cornea thins and bulges outward. Participants must have a specific stage of keratoconus (stage 1), no prior use of certain contact lenses, no corneal scarring, and not have had any previous corneal transplants.

What is being tested?

The study is comparing two types of contact lenses: small diameter corneal gas permeable lenses and large diameter scleral lenses. It aims to determine which lens type offers better visual satisfaction, comfort, and ease of use for people with keratoconus.

What are the potential side effects?

Potential side effects may include discomfort while wearing the lenses, eye irritation or redness, difficulty in placing or removing the lenses, and less commonly, an increased risk of eye infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with keratoconus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have never had corneal transplantation or INTACS.

Select...

I have scarring on my cornea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, study visit 1 (2-4 weeks), study visit 2 (4-10 weeks) and at study completion (6-24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, study visit 1 (2-4 weeks), study visit 2 (4-10 weeks) and at study completion (6-24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, study visit 1 (2-4 weeks), study visit 2 (4-10 weeks) and at study completion (6-24 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Final contact lens choice

Secondary study objectives

Subjective comfort with lens use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Corneal gas permeable lens firstActive Control1 Intervention

Device: corneal gas permeable contact lenses (RoseK2 corneal Blanchard Contact Lens, Inc. Manchester, NH). Participants with an odd study ID will be fit with the corneal gas permeable lens first.

Group II: Scleral lens firstActive Control1 Intervention

Device: scleral lenses (SynergEyes VS (Synergeyes, Inc., Carlsbad CA). Participants with an even study ID will be fit with the scleral lens first.

0 / 3Eligibility criteria met