All > Keratoconus
Photosensitizer

Continuous UVA for Keratoconus

Cornea and Laser Eye Institute, Hersh Vision Group, Teaneck, NJ
Targeting 2 different conditionsriboflavin ophthalmic solutionPhase 3RecruitingResearch Sponsored by Cornea and Laser Eye Institute

Study Summary

This trial found that the accelerated crosslinking method was effective in reducing the progression of keratoconus.

Eligible Conditions
  • Keratoconus
  • Corneal Ectasia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are 18 years or older and have been diagnosed with keratoconus or corneal ectasia after undergoing surgery to correct your vision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: 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 site

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 Director
Cornea 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

Riboflavin Ophthalmic Solution (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT05027295 — Phase 3
Keratoconus Research Study Groups: Continuous UVA, Pulsed UVA
Keratoconus Clinical Trial 2023: Riboflavin Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT05027295 — Phase 3
Riboflavin Ophthalmic Solution (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027295 — Phase 3

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
Recent research and studies
clinicaltrials.govStudy
Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light
2021. "Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027295.
~72 spots leftby Jul 2025
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