← Back to Search

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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with keratoconus.

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Final contact lens choice
Secondary outcome measures
Subjective comfort with lens use

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.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
605 Previous Clinical Trials
1,559,120 Total Patients Enrolled
Ellen S Shorter, OD4.5592 ReviewsPrincipal Investigator - University of Illinois at Chicago
Medical School - Nova Southeastern University, Doctor of Osteopathic Medicine
Westchester General Hospital, Residency in Family Medicine
1Patient Review
This office is disorganized and overbooked, which leads to rushed appointments. I would recommend avoiding this practice.

Media Library

Corneal Gas Permeable Lens (Contact Lens) Clinical Trial Eligibility Overview. Trial Name: NCT04918316 — N/A
Keratoconus Research Study Groups: Corneal gas permeable lens first, Scleral lens first
Keratoconus Clinical Trial 2023: Corneal Gas Permeable Lens Highlights & Side Effects. Trial Name: NCT04918316 — N/A
Corneal Gas Permeable Lens (Contact Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04918316 — N/A
Keratoconus Patient Testimony for trial: Trial Name: NCT04918316 — N/A

Frequently Asked Questions

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

Is enrollment open at this time for the trial?

"Per the details hosted on clinicaltrials.gov, this medical study is actively seeking out patients to parttake in their trials. It was first introduced on July 23rd 2021 and recently updated on May 18th 2022."

Answered by AI

To what capacity is the current clinical trial being populated?

"Affirmative. Clinicaltrials.gov's records demonstrate that this trial, which first appeared online on July 23rd 2021, is still open for recruitment. 125 people are needed to be enrolled from 6 distinct locations."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Other
Nevada
North Carolina
What site did they apply to?
Cornea Center for Clinical Excellence, Illinois Eye Institute, Illinois College of Optometry
Illinois Eye and Ear Infirmary, University of Illinois at Chicago
University of Illinois at Chicago Eye and Ear Infirmary
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How long is the trial? How often do I come there and for how long?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I want to be able to see again. I hope the clinical trial will help. I need a solution to enable me to see to drive.
PatientReceived no prior treatments
I would like to receive further treatment. Any further remedy that can be applied would be appreciated. I would also like that data to be used to help others with Keratoconus or similar conditions.
PatientReceived no prior treatments
I have progressive KC in both eyes treated left in 2018 and needing treatment in right after condition worsening. Ideally help can keep me from further issues and help others dealing with my illness.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Illinois at Chicago Eye and Ear Infirmary: < 48 hours
Average response time
  • < 2 Days
~25 spots leftby Dec 2024