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Treating donor corneas with riboflavin and UV light before transplant for keratoconus

Tests treated donor corneas in people having a transplant for keratoconus.

Key facts

Who runs it
Joseph B. Ciolino, MD
Where
Boston, United StatesSee the site
Trial code
Registry title
A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients
Status
Not yet recruiting
People taking part
216 people, planned
Starts
1 Jan 2027
Expected to end
30 Nov 2028
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light
  • Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light
Record updated
8 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with keratoconus who need a corneal transplant and have never had one. It compares donor corneas treated with cross-linking (a stiffening treatment) to untreated donor corneas.

Age
18 to 50 years
Sex
All sexes
Disease stage
Keratoconus that needs a corneal transplant (keratoplasty).
Earlier treatment
No previous corneal transplant and no previous cross-linking. People must agree to have no further cross-linking, corneal relaxing incisions, intacs or laser vision correction during the study.

Main reasons for not taking part

  • Stevens-Johnson syndrome or ocular pemphigoid, or a current infection
  • Eye or eye-surface infection within 30 days before entry
  • Pregnancy, breastfeeding, or sexually active pre-menopausal women not using reliable birth control
  • Sight in only one eye, uncontrolled glaucoma, or glaucoma surgery or drainage devices
  • Eye cancer, nerve-damaged cornea, or a non-healing corneal wound of at least 0.5x0.5 mm lasting 6 weeks or more

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Signs of current infection, including fever and current treatment with antibiotics
  • Corneal or ocular surface infection within 30 days prior to study entry
  • History of previous cross-linking
  • History of previous corneal transplant
  • History of Stevens-Johnson syndrome or ocular pemphigoid
  • Ocular or periocular malignancy
  • 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; Systemic
  • 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); Recipient Eye
  • Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 50 years old?

Where in United States

  • Massachusetts Eye and Ear InfirmaryBoston, United StatesContact: Joseph Ciolino, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Ex vivo cross linking of donor corneal tissueTreatment being tested

    Treatment Arm: The donor corneal tissue used in the PK or DALK procedures will previously undergo ex vivo crosslinking.

    Treatment: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light

  • Non-cross-linked donor corneal tissue for keratoplastySham treatment, for comparison

    Control Arm: The donor corneal tissue used in the PK or DALK procedures will not previously undergo ex vivo crosslinking.

    Treatment: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus
Plain-language title
Treating donor corneas with riboflavin and UV light before transplant for keratoconusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT04584125, who can take part
Record updated
8 April 2026