Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases

Conditions

• Ectasia of Cornea
• Forme Fruste Keratoconus (FFK)
• Keratoconus
• Pellucid Marginal Corneal Degeneration

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epi-ON corneal cross-linking — COMBINATION_PRODUCT
  Corneal cross-linking involves the following steps: * applying riboflavin (Vitamin B2 eye drops) to the eye, then * exposing the eye to ultraviolet (UV-A) light

Study Details

The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus. The main question it aims to answer is: * Does CXL help prevent or slow the progression of someone's corneal condition and vision loss? Participants will: * Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given. Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light). * There will be two groups of participants. One group will receive the UVA treatment for 18 minutes and the other group will receive the UVA treatment for 24 minutes.

Key Dates

Start date

Aug 1, 2025

Status verified

Jan 2026

Primary completion

Nov 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

485 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: UVA 18 minute
  Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes
• Experimental: UVA 24 minute
  Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes

Primary Outcome Measure

The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes and CDVA. [ Time Frame: From enrollment to the end of treatment at 6 months. ]

Central Contacts

• LuAnn Bryant
  770-804-1684
  [email protected]

Locations (12)

Find similar trials in Atlanta, GA

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