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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 is a NA study that has not yet begun recruiting, run by Joseph B. Ciolino, MD. The registered enrollment target is 216 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04584125
The ClinicalTrials.gov registry entry for NCT04584125 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph B. Ciolino, MD, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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