Recruiting

Corneal Collagen Crosslinking

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT03041883

Conditions

Corneal Melting in Boston Keratoprosthesis Type I

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Crosslinking with riboflavin of the corneal graft-support

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

Study Details

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

Study ID

NCT03041883

Start date

Jan 4, 2017

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Kpro with crosslinked graft-support

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.

active comparator: KPro with normal graft-support

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.

Interventions

Crosslinking with riboflavin of the corneal graft-support

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

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

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

Primary outcome measure

  • Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Marie-Catherine Tessier

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

Soumaya Bouhout

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

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X3E4

Contacts

Marie-Catherine Tessier

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

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-04-28.