Corneal epithelial defect following penetrating keratoplasty Topical insulin, corneal epithelial defect, wound healing, penetrating keratoplasty, corneal transplant, ocular surface, tear cytokines
Conditions
Interventions
25 IU/mL topical insulin eye drops,0.9% NaCl eye drops
Experimental Drug,Placebo Comparator Drug
Topical insulin,Topical normal saline
Sponsors
Faculty of medicine, Chiang Mai University, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who are scheduled for penetrating keratoplasty (full-thickness corneal transplant)
Exclusion criteria
Exclusion criteria: 1. Pre-existing Ocular Conditions: - Patients with active ocular infections, such as bacterial, viral, or fungal infections, at the time of surgery. - Patients with ocular surface disorders that may impair healing, including severe dry eye syndrome, Stevens-Johnson syndrome, or neurotrophic keratopathy. - Patients with a history of recurrent herpes simplex keratitis or other corneal conditions that could affect wound healing. 2. Systemic Health Issues: - Patients with uncontrolled diabetes (HbA1c > 9%), as hyperglycemia could independently impact wound healing regardless of the intervention. - Patients with systemic conditions that may impair wound healing, such as autoimmune disorders (e.g., lupus, rheumatoid arthritis) or immunosuppression resulting from medication or underlying disease. 3. Medications: Patients taking systemic or topical corticosteroids (apart from the standard postoperative regimen) or immunosuppressive agents that could impact corneal healing. Additionally, patients using anti-inflammatory or anti-metabolic drugs that may influence epithelial healing, as well as those using herbal or dietary supplements that could interfere with wound healing and inflammation, such as vitamin C. 4. Pregnancy or lactation: Pregnant or breastfeeding women, as the effects of topical insulin on these populations are not well-studied. 5. Allergies: Known hypersensitivity or allergy to insulin or any component of the topical insulin formulation being used in the study. 6. Previous Corneal Surgeries. Patients who have had prior corneal surgeries or transplants in the same eye, as these may confound the results related to corneal healing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal epithelial healing rate Daily until complete healing Defect area using Chiang Mai Corneal Conjunctival Grading Software (CCC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory cytokines in tear fluid Baseline (Day 0) Day 1 Day 3 IL1beta IL6 IL8 TNFalpha,Insulin in tear fluid Baseline (Day 0) Day 1 Day 3 Insulin,Pain score Daily post-op Visual Analog Scale (VAS),Adverse events Daily post-op Incidence and description of ocular/systemic side effects | — |
Countries
Thailand
Contacts
Public ContactPhit Upaphong
CMU
Outcome results
None listed