40 Participants Needed

Corneal Collagen Crosslinking for Corneal Melting

(CXL-KPro Trial)

MT
SB
Overseen BySoumaya Bouhout
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Marie-Claude Robert
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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).

Research Team

MR

Marie-Claude Robert, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Kpro with crosslinked graft-supportExperimental Treatment1 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-supportActive Control1 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.

Find a Clinic Near You

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+
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