About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Candidate for KPro type I
Capacity to give written consent
Ability to be followed for the duration of the study
Disqualifiers
Participation in another interventional study
Failure to wear a therapeutic contact lens due to abnormalities of the eyelids.
Inability to give written consent
Severe dryness with keratinization of the ocular surface
Trial design
Parallel
Treatments tested in this trial
Crosslinking with riboflavin of the corneal graft-support
Procedure/SurgeryCorneal 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
Procedure/SurgeryCorneal graft-support will be de-epithelialized and soaked with riboflavin and then used with the standard surgical technique
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Comparison of the rates of infectious keratitis between the groups
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
Comparison of the rates of infectious keratitis between the groups
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
Comparison of the rates of infectious keratitis between the groups
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
Comparison of the rates of infectious keratitis between the groups
This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Maisonneuve-Rosemont Hospital
Collaborator