Topical Insulin Versus Autologous Serum After Corneal Surgeries

Benha University

Status and phase: Unknown; Phase 1

Conditions: Corneal Epithelial Wound

Treatments: Drug: autologous serum (AS); Drug: Insulin; Drug: conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT05331859

TIKRS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 3 patient groups, including a placebo group

conventional

Placebo Comparator group

Description:

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated only with conventional postoperative eye drops.

Treatment:

Drug: conventional

Insulin

Active Comparator group

Description:

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with topical insulin and conventional postoperative eye drops.

Treatment:

Drug: conventional

Drug: Insulin

Autologous serum eye drops

Active Comparator group

Description:

Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with Autologous serum eye and conventional postoperative eye drops.

Treatment:

Drug: autologous serum (AS)

Drug: conventional