Corneal Cross-Linking for Keratoconus Transplant Surgery
This study is a clinical trial for people with keratoconus (a condition where the cornea, the clear front part of your eye, thins and bulges) who need a corneal transplant. It's testing if donor corneas that have been treated with a procedure called ex vivo corneal cross-linking improve outcomes. This procedure uses riboflavin 5'-phosphate in 20% dextran ophthalmic solution and ultraviolet (UV) light to strengthen the cornea. You would receive a donor cornea that has either been cross-linked or treated with riboflavin solution but no UV light. Researchers will then measure how much astigmatism (a common vision problem caused by an imperfectly curved cornea) you have 130 weeks after surgery. The study is enrolling 216 participants aged 18 to 50 who have keratoconus and need a transplant, and have not had a previous transplant.
- Study design
- This is a randomized clinical trial with 216 participants. You would be randomly assigned to receive either a cross-linked donor cornea or a non-cross-linked donor cornea, and neither you nor your doctors would know which you received.
- What's involved
- You would have follow-up visits at 1 day, 1 week, 1 month, 6 months, 1 year, 1.5 years, 2 years, and 2.5 years after surgery. You would also need to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision procedures.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for 130 weeks (about 2.5 years) after surgery to measure keratometric astigmatism.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Joseph B Ciolino · PRINCIPAL_INVESTIGATOR · Massachusetts Eye and Ear
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- • Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.130 weeks
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery