Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
NCT07135167 · View on ClinicalTrials.gov ↗
Study Summary
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 8 years of age or older and have a diagnosis of Down syndrome. 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 for 20 minutes).
Conditions Studied
Interventions
- COMBINATION_PRODUCT Epi-ON corneal cross-linking (CXL)
Study Locations (12)
Georgia
- Woolfson Eye Institute — Atlanta
- Woolfson Eye Institute — Atlanta
- Woolfson Eye Institute — Canton
- Woolfson Eye Institute — Cumming
- Woolfson Eye Institute — Douglasville
- Woolfson Eye Institute — Lawrenceville
- Woolfson Eye Institute — Marietta
- Woolfson Eye Institute — Snellville
Tennessee
- Woolfson Eye Institute — Chattanooga
- Woolfson Eye Institute — Johnson City
- Woolfson Eye Institute — Knoxville
North Carolina
- Woolfson Eye Institute — Asheville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07135167
The ClinicalTrials.gov registry entry for NCT07135167 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Woolfson Eye Institute, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Keratoconus appearing as the primary indexed condition, and to 1 intervention — of which Epi-ON corneal cross-linking (CXL) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07135167 reports 12 study locations spanning 3 distinct geographic areas — top geographies include Georgia, Tennessee, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07135167 about?
NCT07135167 is a clinical study titled "Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome". 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 performe...
What is the current status of trial NCT07135167?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2025-08-01. Estimated completion is 2028-12-31.
What conditions does trial NCT07135167 study?
This clinical trial studies the following conditions: Keratoconus, Down Syndrome (DS), Forme Fruste Keratoconus (FFK), Pellucid Marginal Degeneration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07135167?
The interventions under investigation include: Epi-ON corneal cross-linking (CXL) (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07135167?
This trial is sponsored by Woolfson Eye Institute, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07135167 being conducted?
This trial has 12 study locations across Georgia, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.