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ClinicalTrials.gov ID

NCT05331859

Lead Sponsor

Benha UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 1

Enrollment

250Estimated

Last Update Posted

Apr 22, 2022Actual

Start Date

May 2022Estimated

Primary Completion Date

Aug 2022Estimated

Completion Date

Sep 2022Estimated

Official Title

Topical Insulin Versus Autologous Serum and Enhanced Corneal Epithelial Healing After Keratorefractive Surgeries

Brief Summary

The aim of the study is to test whether use of topical insulin or autologous serum eye-drops can promote corneal epithelial healing following photorefractive keratectomy (PRK).

Detailed Description

Topical insulin has been proved recently to enhance the corneal reepithelization rate and manage neurotrophic corneal ulcers unresponsive to conventional treatments. However, its effectiveness on corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) has not been reported. In this study, we plan to perform a prospective non-randomized study to determine the efficacy and safety of topical insulin as a primary treatment for a corneal epithelial defect in patients undergoing the PRK and compare that to autologous serum eye drops. The study eye will receive either the insulin or the serum eye drops, in addition to the conventional treatment, while the control eye will have the standard treatment. For each eligible candidate, the eye with a higher depth of ablation will be the study eye. If even ablation depth in both eyes, the right eye will be selected. The conventional postoperative eye drops include topical moxifloxacin 0.5% (Vigamox; Alcon Laboratories) four times per day, artificial tears (Systane Ultra; Alcon) every two hours, Dexamethasone 0.1% (Maxidex; Alcon Laboratories) four times daily for one month followed by fluorometholone 0.1% (Efemyo; OrchidiaLaboratories) four times daily for another two to four weeks depending on refraction and haze level. In study eyes, the patients receive either topical insulin eye drops or autologous serum in addition to conventional postoperative eye drops until complete epithelial healing. The duration for the corneal surface to completely re-epithelize, the grade of postoperative corneal haze, 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 distant corrected visual acuity will be compared between these three groups.

• Corneal Epithelial Wound

• Insulin
• autologous serum (AS)
• conventional

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• stable refraction of at least one year, normal corneal topography, and a minimum central corneal thickness of 500 μm.

Exclusion Criteria:

• unstable refraction, dry eye, blepharitis, corneal disease, glaucoma, systemic diseases including infectious and collagen vascular diseases, diabetes, and topographical evidence of keratoconus.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Benha UniversityOTHER

taher.eleiwa@fmed.bu.edu.eg01069901973