Topical Infliximab in Eyes With Penetrating Keratoplasty
- Conditions
- Glaucoma Following Surgery
- Registration Number
- NCT05180994
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - Age between 18 and 80 years;<br><br> - First corneal transplant surgery;<br><br> - Capable of providing informed consent;<br><br> - Capable of administering eye medication or access to a caregiver able and willing to<br> administer the eye medication for the patient.<br><br>Exclusion Criteria:<br><br> - Active ocular infection;<br><br> - Past corneal transplant (any technique);<br><br> - Advanced glaucoma or macular disease;<br><br> - Active or latent systemic infection (tuberculosis, histoplasmosis,<br> coccidioidomycosis, cytomegalovirus, pneumocystis, aspergillosis or hepatitis B);<br><br> - Malignancy diagnosed in the past 5 years (any kind);<br><br> - Demyelinating disease;<br><br> - History or current diabetes mellitus (controlled or uncontrolled) or heart failure<br> (New York Heart Association class III or IV);<br><br> - Pregnancy or breastfeeding;<br><br> - Allergy to infliximab or to a compound of its topical formulation;<br><br> - Significant anomaly of complete blood count or hepatic enzymes;<br><br> - Current or anterior use of anti-TNF-a medication or other anti-inflammatory<br> biologics.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complications associated to PKP surgery;Complications associated to infliximab use
- Secondary Outcome Measures
Name Time Method Mean retinal nerve fiber thickness;Occurrence of glaucoma;Best Corrected Visual Acuity (BCVA);Ocular surface symptoms;Quantification of ocular surface inflammation;Quantification of anterior chamber inflammation;Epithelial healing time;Incidence of epithelial keratitis