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Procedure

Corneal Collagen Crosslinking for Corneal Melting (CXL-KPro Trial)

N/A

Recruiting

Led By Marie-Claude Robert, MD

Research Sponsored by Marie-Claude Robert

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

CXL-KPro Trial Summary

This trial is testing a new way to make a cornea transplant last longer in people with a certain type of eye disease.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, sensitivity to light, temporary vision changes, and a risk of infection or inflammation. Long-term effects are being studied as part of this trial.

CXL-KPro Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cornea

Secondary outcome measures

Comparison of the rates of extrusion of the KPro between the groups

Comparison of the rates of infectious keratitis between the groups

Comparison of the visual acuity between the groups

CXL-KPro Trial Design

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Marie-Claude RobertLead Sponsor

1 Previous Clinical Trials

37 Total Patients Enrolled

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,597 Total Patients Enrolled

Maisonneuve-Rosemont HospitalOTHER

99 Previous Clinical Trials

36,283 Total Patients Enrolled

Media Library

Corneal Collagen Crosslinking (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03041883 — N/A

Corneal Melting Research Study Groups: KPro with normal graft-support, Kpro with crosslinked graft-support

Corneal Melting Clinical Trial 2023: Corneal Collagen Crosslinking Highlights & Side Effects. Trial Name: NCT03041883 — N/A

Corneal Collagen Crosslinking (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03041883 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program open to minors?

"According to the eligibility requirements of this research, individuals must be at least 18 years old and no more than 80."

Answered by AI

What is the current status of enrollment for this clinical trial?

"As per the details on clinicaltrials.gov, this research is actively enrolling participants. It was initially published on April 1st 2017 and its most recent update was July 4th 2022."

Answered by AI

What are the eligibility requirements for participation in this research project?

"To be accepted into the clinical trial, patients must have a corneal ulcer and may not exceed 80 years of age. The study has 40 slots in total."

Answered by AI

How many individuals are participating in this research project?

"Affirmative. The information hosted on clinicaltrials.gov verifies that the medical experiment, originally posted on April 1st 2017 is currently recruiting volunteers. 40 individuals are needed from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Corneal Collagen Crosslinking to Increase the Resistance of the Support Graft of the KPro Type I Against Corneal Melting

Marie-Claude Robert 2017. "Corneal Collagen Crosslinking to Increase the Resistance of the Support Graft of the KPro Type I Against Corneal Melting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03041883.