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?

This trial tests corneal collagen crosslinking for individuals with corneal melting, a condition where the cornea (the clear front part of the eye) begins to break down. The trial compares two groups: one receiving a normal graft (a piece of tissue) and the other receiving a crosslinked graft with added treatment for increased strength. The goal is to determine if the crosslinked graft can better support a special type of artificial cornea implant and prevent further eye damage. Candidates may be suitable if they are set to receive this type of implant and can attend follow-up appointments throughout the study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatments for corneal conditions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that corneal collagen crosslinking is safe for corneal melting?

Research has shown that corneal collagen crosslinking, a treatment using vitamin B2 (riboflavin) and ultraviolet A light, is generally safe. Studies have found that most people tolerate this procedure well, with side effects usually being minor and temporary. However, some risks exist. In rare cases, serious issues like corneal clouding or infections can occur. Despite these rare problems, many clinical trials have found it to be a very safe procedure overall, with few complications. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Corneal Collagen Crosslinking (CXL) is unique because it offers a promising approach to treating corneal melting by strengthening the cornea through a process called crosslinking. This technique uses riboflavin (vitamin B2) and ultraviolet A (UVA) light to create chemical bonds within the corneal tissue, enhancing its structural integrity. Unlike standard treatments such as corticosteroids or surgical interventions, which primarily focus on managing symptoms or replacing damaged tissue, CXL aims to directly halt the progression of corneal degradation. Researchers are excited about this treatment because it has the potential to provide a more durable solution by reinforcing the corneal structure itself, reducing the need for repeated surgeries or long-term medication use.

What evidence suggests that corneal collagen crosslinking is effective for corneal melting?

Research shows that corneal collagen crosslinking, which uses riboflavin and ultraviolet A light, strengthens the cornea by creating new collagen bonds. This process likely makes the cornea more resistant to thinning or damage. Studies have found that some patients experience better vision and improved sharpness after the treatment. By stiffening the cornea, this treatment might also reduce swelling and increase comfort. In this trial, one group will receive a crosslinked corneal graft-support for the Boston keratoprosthesis, which early evidence suggests could help prevent issues like corneal damage. Another group will receive a normal graft-support for comparison. ^{1 2 3 6 7}

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

Inability to give written consent

Participation in another interventional study

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3094293/

Corneal melting after collagen cross-linking for keratoconus In this report, we demonstrate a case of corneal melting after corneal collagen cross-linking for keratoconus corneas associated with an acute inflammatory ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11503234/

Progression of corneal thinning and melting after collagen ... The incidence of corneal thinning after collagen cross-linking is less but fulminant, requiring timely and appropriate management to prevent visual ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2162098923006485

Corneal Collagen Cross-linking: A Review of Clinical ... It was found that the mean best spectacle-corrected visual acuity improved by 1.9 Snellen lines, and the mean uncorrected visual acuity improved by 2.7 Snellen ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03041883

Corneal Collagen Crosslinking to Increase the Resistance ... 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 ...

5. reviewofophthalmology.com reviewofophthalmology.com/article/whats-next-for-corneal-crosslinking

What's Next for Corneal Cross-Linking By increasing stromal rigidity through collagen cross-link formation, CXL may reduce corneal edema and improve patient comfort. The strengthened ...

6. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03400-1

Management of corneal melting after collagen cross-linking for ... Although CXL is considered a safe procedure, in rare cases it can lead to serious complications, such as corneal haze, infectious and non- ...

7. aaojournal.org aaojournal.org/article/S0161-6420(24)00282-3/fulltext

Safety and Efficacy of Epithelium-Off Corneal Collagen ... Improvement in the maximum keratometry (Kmax) value, corrected distance visual acuity (CDVA), and uncorrected distance visual acuity (UDVA) was ...