Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041883
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Centre hospitalier de l'Université de Montréal (CHUM)
Maisonneuve-Rosemont Hospital
Information provided by (Responsible Party):
Marie-Claude Robert, Centre hospitalier de l'Université de Montréal (CHUM)

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).

Condition or disease Intervention/treatment Phase
Corneal Melting in Boston Keratoprosthesis Type I Procedure: Crosslinking with riboflavin of the corneal graft-support Procedure: De-epithelisation of the corneal graft support with instillation of riboflavin Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Corneal Collagen Crosslinking to Increase the Resistance of the Graft Used as a Support for the Boston Keratoprosthesis Type I Against Corneal Melting
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arm Intervention/treatment
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.
Procedure: Crosslinking with riboflavin of the corneal graft-support
Corneal graft support for the KPro will be crosslinked and used with the standard surgical technique

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.
Procedure: 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 Measures :
  1. 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 ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  2. 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 ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  3. 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 ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  4. 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 ]
    This visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  5. 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 ]
    An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.

  6. 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 ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  7. 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 ]
    These visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  8. 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 ]
    An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.

  9. 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 ]
    An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.

  10. 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 ]
    An imaging allowing quantification of the thickness of the cornea graft-support (optical coherence tomography anterior segment) will be performed.


Secondary Outcome Measures :
  1. Comparison of the rates of infectious keratitis between the groups [ Time Frame: 1 day ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  2. Comparison of the rates of infectious keratitis between the groups [ Time Frame: 1 week ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  3. Comparison of the rates of infectious keratitis between the groups [ Time Frame: 2 weeks ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  4. Comparison of the rates of infectious keratitis between the groups [ Time Frame: 1 month ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  5. Comparison of the rates of infectious keratitis between the groups [ Time Frame: 3 months ]
    This visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  6. Comparison of the rates of infectious keratitis between the groups [ Time Frame: Every to 2-4 months depending on the judgment of the surgeon for at least 5 years ]
    These visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  7. Comparison of the rates of extrusion of the KPro between the groups [ Time Frame: 1 day ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  8. Comparison of the rates of extrusion of the KPro between the groups [ Time Frame: 1 week ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  9. Comparison of the rates of extrusion of the KPro between the groups [ Time Frame: 2 weeks ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  10. Comparison of the rates of extrusion of the KPro between the groups [ Time Frame: 1 month ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  11. Comparison of the rates of extrusion of the KPro between the groups [ Time Frame: 3 months ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  12. Comparison of the rates of extrusion of the KPro between the groups [ Time Frame: Every to 2-4 months depending on the judgment of the surgeon for at least 5 years ]
    These visits will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  13. Comparison of the visual acuity between the groups [ Time Frame: 1 day ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  14. Comparison of the visual acuity between the groups [ Time Frame: 1 week ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  15. Comparison of the visual acuity between the groups [ Time Frame: 2 weeks ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  16. Comparison of the visual acuity between the groups [ Time Frame: 1 month ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  17. Comparison of the visual acuity between the groups [ Time Frame: 3 months ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.

  18. Comparison of the visual acuity between the groups [ Time Frame: Every to 2-4 months depending on the judgment of the surgeon for at least 5 years ]
    This visit will include measurement of visual acuity and intraocular pressure and a full slit-lamp examination.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041883


Contacts
Layout table for location contacts
Contact: Marie-Catherine Tessier 514-890-8000 ext 11550 marie-catherine.tessier.chum@ssss.gouv.qc.ca
Contact: Soumaya Bouhout 514-264-0436 soumiya.bouhout@gmail.com

Locations
Layout table for location information
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X3E4
Contact: Marie-Catherine Tessier    514 890-8000 ext 11550    marie-catherine.tessier.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Marie-Claude Robert
Centre hospitalier de l'Université de Montréal (CHUM)
Maisonneuve-Rosemont Hospital
Investigators
Layout table for investigator information
Principal Investigator: Marie-Claude Robert, MD Centre hospitalier de l'Université de Montréal (CHUM)

Layout table for additonal information
Responsible Party: Marie-Claude Robert, MD, MSc, Department of Ophthalmology, University of Montreal, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03041883    
Other Study ID Numbers: CE14.362
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Ulcer
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents