Topical Insulin Versus Autologous Serum After Corneal Surgeries

April 15, 2022 updated by: Taher Eleiwa, Benha University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Kalyobeya
      • Banha, Kalyobeya, Egypt, 13512
        • Ebsar Eye Centre
        • Contact:
          • Abdelmonem Hamed, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: conventional
Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated only with conventional postoperative eye drops.
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.
Active Comparator: Insulin
Corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) treated with topical insulin and conventional postoperative eye drops.
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.
Drug: 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.
Active Comparator: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration for the corneal surface to completely re-epithelialize.
Time Frame: up to 6 weeks
up to 6 weeks
Grade of postoperative corneal haze
Time Frame: 6 weeks
0, completely clear cornea; +0.5, barely visible corneal opacity; +1, reticular subepithelial opacities not interfering with visibility of fine iris details; +2, punctate or coalesced subepithelial opacities with mild obscuration of iris details; +3, confluent subepithelial opacities with moderate obscuration of the iris and lens; and +4, dense opacities with complete opacification of the stroma.
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, sterile corneal ulcer, corneal melting, corneal neovascularization).
Time Frame: 6 weeks
6 weeks
Best-corrected Visual Acuity improvement (Snellen, decimal)
Time Frame: Before and after treatment completion, assessed up to 6 weeks
Before and after treatment completion, assessed up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Taher Eleiwa, MD PhD, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

April 10, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIKRS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The completed data will be shared upon a reasonable request to the principal investigator.

IPD Sharing Time Frame

For 1 year after the publishing the results

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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