Topical Insulin Versus Autologous Serum After Corneal Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2022-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Corneal Epithelial Wound

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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conventional

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

Group Type PLACEBO_COMPARATOR

conventional

Intervention Type DRUG

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 then fluorometholone 0.1% (Efemyo; Orchidia Laboratories) four times daily for another two to four weeks depending on refraction and haze level.

Insulin

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

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Topical insulin drops will be prepared by diluting 1 unit of rapid-acting insulin per 1 mL of an artificial tear with a propylene glycol base. Drops will be preserved at low temperature (2ºC) and applied four times a day.

conventional

Intervention Type DRUG

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 then fluorometholone 0.1% (Efemyo; Orchidia Laboratories) four times daily for another two to four weeks depending on refraction and haze level.

Autologous serum eye drops

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

Group Type ACTIVE_COMPARATOR

autologous serum (AS)

Intervention Type DRUG

Whole blood (20 ml) wll be procured by venipuncture, centrifuged at 1,500 revolutions per minute (relative centrifugal force of 25.15 × g) for 10 minutes. AS drops will be carefully prepared under a laminar airflow cabinet, and diluted with artificial tears (Systane ultra; Alcon) to 20%. AS drops will be prepared on the day of surgery and patients will be asked to keep AS drops refrigerated at about 4C.

conventional

Intervention Type DRUG

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 then fluorometholone 0.1% (Efemyo; Orchidia Laboratories) four times daily for another two to four weeks depending on refraction and haze level.

Interventions

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Insulin

Topical insulin drops will be prepared by diluting 1 unit of rapid-acting insulin per 1 mL of an artificial tear with a propylene glycol base. Drops will be preserved at low temperature (2ºC) and applied four times a day.

Intervention Type DRUG

autologous serum (AS)

Whole blood (20 ml) wll be procured by venipuncture, centrifuged at 1,500 revolutions per minute (relative centrifugal force of 25.15 × g) for 10 minutes. AS drops will be carefully prepared under a laminar airflow cabinet, and diluted with artificial tears (Systane ultra; Alcon) to 20%. AS drops will be prepared on the day of surgery and patients will be asked to keep AS drops refrigerated at about 4C.

Intervention Type DRUG

conventional

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 then fluorometholone 0.1% (Efemyo; Orchidia Laboratories) four times daily for another two to four weeks depending on refraction and haze level.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No