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.

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NCT04584125

A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients

Not Yet Recruiting
NAAges 18–50InterventionalTreatment
Joseph B. Ciolino, MD
~216 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV lightRiboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.
Measured over 130 weeks
Keratoconus
1 sites across 1 states
Massachusetts1
  • Joseph B Ciolino · PRINCIPAL_INVESTIGATOR · Massachusetts Eye and Ear

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willing and able to provide written informed consent.
Willing and able to comply with study assessments for the full duration of the study.
Age ≥18 years but ≤50 years
History of keratoconus (without a previous transplant) requiring keratoplasty
Willing to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision correction during the course of the study

Exclusion

Age \< 18 years \>50
Inability to provide written informed consent and comply with study assessments for the full duration of the study
Participation in another simultaneous interventional medical investigation or trial
History of Stevens-Johnson syndrome or ocular pemphigoid
Signs of current infection, including fever and current treatment with antibiotics
Pregnancy (positive pregnancy test) or lactating
Pre-menopausal sexually active women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
Corneal or ocular surface infection within 30 days prior to study entry
History of previous cross-linking
History of previous corneal transplant
Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
Ocular or periocular malignancy
Lid abnormalities that in the opinion of the investigator could confound the study results and these include clinically significant ectropion, lagophthalmos, cicatrization, entropion, and rosacea
Neurotrophic cornea
Monocular
Uncontrolled glaucoma
Glaucoma filtering devices or trabeculectomies
  • • Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.130 weeks

    • Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery