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NCT04584125 · ClinicalTrials.gov registry record · NA
A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients
A NA study, sponsored by Joseph B. Ciolino, MD.
- Not yet
- Registry status
- NA
- Development phase
- 216
- Enrollment target
NCT04584125: Clinical Trial NA study, sponsored by Joseph B. Ciolino, MD.
NCT04584125 is a NA study that has not yet begun recruiting, run by Joseph B. Ciolino, MD. The registered enrollment target is 216 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04584125, a NA study, has not yet begun recruiting, sponsored by Joseph B. Ciolino, MD.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
Study Summary
This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.
Primary Outcome
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery
Interventions
- DRUG Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light
- DRUG Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2028-11-30 |
| Phase | NA |
What is known before NCT04584125 opens enrollment
NCT04584125 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light is the first listed.
NCT04584125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04584125 about?
NCT04584125 is a clinical study titled "A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients". This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-l...
What is the current status of trial NCT04584125?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 216 participants. The study started on 2027-01-01. Estimated completion is 2028-11-30.
What interventions are being tested in trial NCT04584125?
The interventions under investigation include: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light (DRUG), Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light (DRUG).
Who is sponsoring clinical trial NCT04584125?
This trial is sponsored by Joseph B. Ciolino, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04584125's enrollment target sits among peer trials
216 485th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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