Corneal Collagen Crosslinking for Corneal Melting

(CXL-KPro Trial)

Overseen By Soumaya Bouhout

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marie-Claude Robert

Disqualifiers: Severe dryness, Intraocular tumor, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to demonstrate the safety and efficacy of the corneal collagen crosslinking with riboflavin and ultraviolet A in aim to increase the resistance of the graft used as a support for the Boston keratoprosthesis (KPro) type I against corneal melting (keratolysis or sterile necrosis).

Who Is on the Research Team?

Marie-Claude Robert, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for individuals who need a Boston keratoprosthesis (KPro) type I due to severe eye conditions like intraocular tumors or terminal glaucoma. Participants must be able to give written consent and commit to the study's duration. Those unable to wear contact lenses due to eyelid issues or currently in another interventional study cannot join.

Inclusion Criteria

Ability to be followed for the duration of the study

Candidate for KPro type I

I can sign and understand the consent form.

Exclusion Criteria

Participation in another interventional study

Inability to give written consent

I can't wear contact lenses due to eyelid issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive KPro surgery with either a crosslinked or normal graft-support

1 day

1 visit (in-person)

Postoperative Follow-up

Postoperative care including visual acuity and intraocular pressure measurements, slit-lamp examination, and imaging

3 months

Visits at 1 day, 1 week, 2 weeks, 1 month, and 3 months

Long-term Follow-up

Continued monitoring for complications and visual acuity, with imaging repeated at 1, 2, and 5 years

5 years

Every 2-4 months depending on the judgment of the surgeon

What Are the Treatments Tested in This Trial?

Interventions

• Corneal Collagen Crosslinking

Trial Overview The trial tests corneal collagen crosslinking with riboflavin and ultraviolet A light on grafts supporting KPro type I, aiming to prevent corneal melting. The procedure involves removing the surface layer of the graft and applying riboflavin before UV exposure.

How Is the Trial Designed?

Group I: Kpro with crosslinked graft-support Experimental Treatment 1 Intervention

Patient will receive a crosslinked corneal graft-support for the KPro type I. Under sterile conditions, the corneo-scleral button will be inspected, then placed on an artificial anterior chamber. The epithelium of the donor will be removed mechanically. Then one drop of riboflavin 0.1%/dextran 20% will be applied to 3 minutes on the de-epithelialized cornea for 15 minutes. Then, the source of ultraviolet A (UVA) will be irradiating the cornea for 30 minutes with a wavelength of 370 nanometer(nm) length with 5.4 joules(J)/ square centimeter (cm2) and 3 milliwatts(mW)/cm2. Meanwhile, the instillation of a drop of 0.1% riboflavin/dextran 20% continues every 5 minutes. Goggles against UVA are mandatory. The crosslinked graft-support will be forwarded to the surgeon according to standard procedure.

Group II: KPro with normal graft-support Active Control 1 Intervention

Patient wil receive a normal graft-support for the KPro type I. Under sterile conditions, the corneo-scleral button will be inspected, then placed on an artificial anterior chamber. The epithelium of the donor will be removed mechanically. Then, one drop of riboflavin 0.1% / dextran 20% will be applied to 30 secondes for 5 minutes on the de-epithelialized cornea.The minimally manipulated normal graft-support will be forwarded to the surgeon according to standard procedure.

Who Is Running the Clinical Trial?

Marie-Claude Robert

Lead Sponsor

Trials

2

Recruited

80+

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Maisonneuve-Rosemont Hospital

Collaborator

Trials

102

Recruited

38,300+