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Photosensitizer
Corneal Collagen Crosslinking for Keratoconus
Phase 3
Recruiting
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
18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
Axial topography consistent with keratoconus or post-surgical corneal ectasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial found that the accelerated crosslinking method was effective in reducing the progression of keratoconus.
Who is the study for?
Adults diagnosed with keratoconus or corneal ectasia following refractive surgery can join. They must have specific corneal steepening, be willing to follow the visit schedule, and not wear contact lenses for a week before screening. Pregnant women, those planning pregnancy, lactating individuals, or people with certain eye conditions or sensitivities are excluded.Check my eligibility
What is being tested?
The trial is testing an accelerated method of strengthening the cornea using riboflavin ophthalmic solution and UV-A light (either pulsed or continuous). The goal is to see if this speeds up oxygenation and improves treatment outcomes for patients with keratoconus or ectasia.See study design
What are the potential side effects?
Potential side effects may include discomfort during UV exposure, temporary vision changes, inflammation of the eye, possible scarring in the treatment zone, and delayed healing of the cornea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with a diagnosis of keratoconus or corneal ectasia.
Select...
My eye condition is related to keratoconus or corneal ectasia after surgery.
Select...
I am 18 or older with a diagnosis of keratoconus or corneal ectasia.
Select...
My eye condition is related to keratoconus or corneal ectasia after surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum keratometry
Secondary outcome measures
Mean keratometry
Trial Design
2Treatment groups
Active Control
Group I: Continuous UVAActive Control1 Intervention
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time
Group II: Pulsed UVAActive Control1 Intervention
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time
Find a Location
Who is running the clinical trial?
Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
943 Total Patients Enrolled
9 Trials studying Keratoconus
943 Patients Enrolled for Keratoconus
Peter S Hersh, MDStudy DirectorCornea and Laser Eye Institute, Hersh Vision Group
4 Previous Clinical Trials
343 Total Patients Enrolled
4 Trials studying Keratoconus
343 Patients Enrolled for Keratoconus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older with a diagnosis of keratoconus or corneal ectasia.My eye condition is related to keratoconus or corneal ectasia after surgery.I have removed my contact lenses for a week before my eye test.I can attend all scheduled follow-up visits.I have noticeable scarring in the treated eye area.I do not have any conditions like nystagmus that would prevent me from keeping my gaze steady during treatments.I can attend all scheduled follow-up visits.You have a central or inferior steepening on the Pentacam map.I am 18 or older with a diagnosis of keratoconus or corneal ectasia.I can remove my contact lenses for a week before the eye test.You have an allergy or sensitivity to the study drugs.You have a condition that could make it difficult for your skin to heal properly.I have had a chemical injury or slow healing in my eye.I have had eye conditions that could cause future issues, excluding vision correction needs.My eye condition is related to keratoconus or corneal ectasia after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous UVA
- Group 2: Pulsed UVA
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be given this medication as part of the research?
"That is correct, the information available on clinicaltrials.gov indicates that the trial is currently underway and looking for 170 individuals from 1 locations."
Answered by AI
Are new patients needed for this ongoing research project?
"The clinicaltrials.gov website indicates that the trial is still looking for subjects. According to the site, the 170 patients are needed at a single location. The trial was posted on 7/30/2021 and was last updated 9/15/2021."
Answered by AI
For what conditions is Pulsed UVA therapy most often the first line of treatment?
"Pulsed UVA is an effective treatment for dietary and nutritional therapies, vitamin deficiency, and joint pain."
Answered by AI
Has the FDA cleared Pulsed UVA for public use?
"There is some evidence to support Pulsed UVA's efficacy, as this is a Phase 3 trial. Furthermore, there is enough safety data from multiple rounds of testing to give it a safety score of 3."
Answered by AI
What are some other examples of research that has been done using Pulsed UVA?
"Pulsed UVA is being trialed in 20 different studies at the moment, 11 of which are in the 3rd stage of clinical trials. The majority of research centres for Pulsed UVA are located in San Francisco, but there are a total of 47 sites running these tests."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
Other
Nevada
How old are they?
65+
18 - 65
What site did they apply to?
Cornea and Laser Eye Institute, Hersh Vision Group
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Typically responds via
Email
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