Topical Insulin Versus Autologous Serum After Corneal Surgeries

What Was Tested

The trial (phase 1) is built around Insulin (regular human).

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).

It had three arms (groups): conventional (placebo comparator), Insulin (active comparator) and Autologous serum eye drops (active comparator).

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

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

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

The registry classes the interventions as drug.

More on the Plan

Topical insulin has been proved recently to enhance the corneal reepithelization rate and manage neurotrophic corneal ulcers unresponsive to conventional treatments.

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.

Who Took Part

The registry lists 250 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Stable refraction of at least one year, normal corneal topography, and a minimum central corneal thickness of 500 μm.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: unstable refraction, dry eye, blepharitis, corneal disease, glaucoma, systemic diseases including infectious and collagen vascular diseases, diabetes, and topographical evidence of keratoconus.

How the Study Was Run

It was run as a non-randomized, parallel-group and double-blind study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2022-05 with completion listed for 2022-08.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Duration for the corneal surface to completely re-epithelialize (time frame: up to 6 weeks). Grade of postoperative corneal haze (time frame: 6 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Insulin (regular human) in 250 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.