Topical Infliximab in Eyes With Penetrating Keratoplasty
Who is this study for? Patients receiving a first penetrating keratoplasty surgery
What treatments are being studied? Infliximab
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Penetrating keratoplasty is a cornea surgery involving several inflammatory complications, of which the most important is glaucoma. Researchers wish to determine whether it is safe to administer infliximab (an anti-inflammatory drug) eye drops after surgery, and whether this eye drop could prevent the occurrence of glaucoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Age between 18 and 80 years;
• First corneal transplant surgery;
• Capable of providing informed consent;
• Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient.
Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Contact Information
Primary
Zobelle Tchouaga
zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.ca
514 890-8000
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 50
Treatments
Experimental: Topical infliximab following PKP surgery
Additionally to standard post-operative regimen, patients who will be undergoing their first PKP surgery and who meet all inclusion and no exclusion criteria will be included in the experimental group. These patients will administer topical infliximab four times per day for 3 months.
Active_comparator: No topical infliximab following PKP surgery
Patients who will be undergoing their first PKP surgery, but who are not qualified to receive infliximab or who refuse to receive infliximab, will be included in the control group. These patients will only administer the standard post-operative regimen following their PKP surgery and will not administer topical infliximab. They will be followed with the same follow-up schedule, questionnaires, examinations and non-invasive tests (excluding lab work) as patients in the interventional group.
Related Therapeutic Areas
Sponsors
Collaborators: Prism Eye Institute, Niagara Health System, Maisonneuve-Rosemont Hospital, Ottawa Hospital Research Institute, Fonds de recherche en ophtalmologie de l'Université de Montréal
Leads: Centre hospitalier de l'Université de Montréal (CHUM)