RecruitingNot ApplicableNCT03041883

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

Corneal Collagen Crosslinking to Increase the Resistance of the Graft Used as a Support for the Boston Keratoprosthesis Type I Against Corneal Melting


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

40 participants

Start Date

Jan 4, 2017

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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

Exclusion Criteria9

  • 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

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Interventions

PROCEDURECrosslinking with riboflavin of the corneal graft-support

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

PROCEDUREDe-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


Locations(1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

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NCT03041883