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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Crosslinking with riboflavin of the corneal graft-support

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Kpro with crosslinked graft-supportExperimental treatment 1 intervention
Group B: KPro with normal graft-supportActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day
2

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.

Time frame
1 week
3

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.

Time frame
2 weeks
4

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.

Time frame
1 month

Secondary outcomes

1

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.

Time frame
1 day
2

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.

Time frame
1 week
3

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.

Time frame
2 weeks
4

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.

Time frame
1 month

Other outcomes

Sponsors and contacts

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