Topical Autologous Insulin Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Topical insulin application has been proved recently to increase corneal reepithelization rate over diabetic animals. However, its effectiveness on corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty has not been reported. In this study, we plan to perform a prospective randomized study to determine the effectiveness of topical insulin as a primary treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and penetrating keratoplasty. All patients enrolled in this study have received corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic retinopathy and penetrating keratoplasty. The patients were randomized into two treatment groups. In the control group, the patients receive conventional postoperative eye drops including topical steroid, antibiotic and mydriatics. In the experimental group, the patients receive topical insulin eye drops in addition to conventional postoperative eye drops. The duration for the corneal surface to completely re-epithelize, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of recurrent epithelial break down after initial epithelization will be compared between these two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty will be compared separately.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Insulin; Insulin, Globin Zinc; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Diabetic patients with proliferative retinopathy receiving PPV

• Patients qualified for penetrating keratoplasty

• DM control blood sugar AC < 200mg/dl

• no limbus defect

• no glaucoma before and after surgery

• Patients willing to receive surgery, blood drawl and OPD follow up

• no previous corneal epithelial defect or disease

Exclusion Criteria:

• Limbus defect

• postsurgical use of other eye drops

• incomplete eyelid closure

• glaucoma

• unable to be followed up postoperatively

• poor visual acuity or poor prognostic visual acuity

• corneoneuropathy

• severe dry eye syndrome

• pregnant

• receive eye surgery within one month after the previous eye surgery