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.
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.
Active ocular infection;
Past corneal transplant (any technique);
Advanced glaucoma or macular disease;
Active or latent systemic infection (tuberculosis, histoplasmosis, coccidioidomycosis, cytomegalovirus, pneumocystis, aspergillosis or hepatitis B);
Parallel
Topical infliximab
DrugInfliximab eye drops (10mg/ml) administered four (4) times per day for three (3) months.
No topical infliximab
Other interventionNo treatment with infliximab.
Complications associated to PKP surgery
Number and type of complications associated to PKP surgery (graft loss, infectious keratitis, graft failure, corneal melting…)
Complications associated to infliximab use
Number and type of complications associated with infliximab use (serious infections, allergic reactions, heart failure, blood problems, nervous system disorders, malignancies…; these complications have been observed with intravenous infliximab administration).
Mean retinal nerve fiber thickness
Percentage of patients presenting with a thinning of mean retinal nerve fiber thickness measured using OCT, with thinning in four quadrants (inferior, superior, nasal, temporal).
Occurrence of glaucoma
Proportion of patients without glaucoma over time.
Best Corrected Visual Acuity (BCVA)
Mean change in BCVA compared to baseline BCVA, measured using a Snellen chart.
Ocular surface symptoms
Ocular surface symptoms as assessed by the Ocular Surface Disease Index (OSDI) questionnaire, ranging from 0 to 100, where a higher score indicates increased disease severity.
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Fonds de recherche en ophtalmologie de l'Université de Montréal
Collaborator
Maisonneuve-Rosemont Hospital
Collaborator
Niagara Health System
Collaborator
Prism Eye Institute
Collaborator
Ottawa Hospital Research Institute
Collaborator
