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

NCT03041883 | Recruiting

• 1 other identifier: CE14.362
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Corneal Melting in Boston Keratoprosthesis Type I

Outcome Measures

Primary Outcomes (10)

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  1 day

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  1 week

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  2 weeks

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  This visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  1 month

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.

  1 month

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  3 months

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  These visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  Every 2-4 months depending on the judgment of the surgeon for at least 5 years

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.

  1 year

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.

  2 years

• Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button

  An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.

  5 years

Secondary Outcomes (18)

• Comparison of the rates of infectious keratitis between the groups

  1 day

• Comparison of the rates of infectious keratitis between the groups

  1 week

• Comparison of the rates of infectious keratitis between the groups

  2 weeks

• Comparison of the rates of infectious keratitis between the groups

  1 month

• Comparison of the rates of infectious keratitis between the groups

  3 months

Study Arms (2)

Kpro with crosslinked graft-support

EXPERIMENTAL

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.

Procedure: Crosslinking with riboflavin of the corneal graft-support

KPro with normal graft-support

ACTIVE COMPARATOR

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.

Procedure: De-epithelisation of the corneal graft support with instillation of riboflavin

Interventions

Crosslinking with riboflavin of the corneal graft-support PROCEDURE

Corneal graft support for the KPro will be crosslinked and used with the standard surgical technique

Kpro with crosslinked graft-support

De-epithelisation of the corneal graft support with instillation of riboflavin PROCEDURE

Corneal graft-support will be de-epithelialized and soaked with riboflavin and then used with the standard surgical technique

KPro with normal graft-support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for KPro type I
• Capacity to give written consent
• Ability to be followed for the duration of the study

You may not qualify if:

• Participation in another interventional study
• Failure to wear a therapeutic contact lens due to abnormalities of the eyelids.
• Inability to give written consent
• Contraindications to the KPro type I:
• Severe dryness with keratinization of the ocular surface
• Intraocular tumor
• Terminal glaucoma
• Inoperable retinal detachment
• Phthisis bulbi

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Maisonneuve-Rosemont Hospital: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X3E4, Canada

RECRUITING

Related Publications (1)

• Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

  PMID: 32557558 DERIVED

Study Officials

• Marie-Claude Robert, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Catherine Tessier

CONTACT

514-890-8000; marie-catherine.tessier.chum@ssss.gouv.qc.ca

Soumaya Bouhout

CONTACT

514-264-0436; soumiya.bouhout@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 3, 2017
• Study Start: January 4, 2017
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CA (1)