The effect of topical insulin eye drops on corneal epithelial wound healing after corneal collagen cross-linking in keratoconus management: a Paired-Eye study

NCT ID NCT07812129

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By invitation only
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Ongoing
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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First seen Sep 10, 2026 ยท Last updated Sep 10, 2026

Summary

The goal of this clinical trial was to learn if topical insulin eye drops affected corneal epithelial wound healing after corneal collagen cross-linking. The main questions it aimed to answer were: Does topical insulin accelerate corneal epithelial healing after corneal collagen cross-linking? Does it affect post-operative pain? Participants were all diagnosed as having bilateral progressive Keratoconus and were already scheduled for bilateral cross-linking: Post-operatively, they were asked to apply insulin eye drops in one eye only (4 times daily) in addition to the prescribed routine post-operative treatment which was applied to both eyes. They were also asked to come for follow-up visits on post-operative day 1,2,3,5 and 7 or until complete corneal wound healing. The epithelial defect was measured in each eye and the participants were asked to report the degree of pain they felt in each eye at each visit until complete epithelial healing.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

24 people

The number who actually took part.

Started

Nov 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Patients above 18 years old diagnosed with bilateral progressive Keratoconus with central corneal thickness more than 400 microns at thinnest location. Exclusion Criteria: * Patients with signs of infectious keratitis (bacterial, fungal, protozoal or mixed poly-microbial). * Patients with a history of herpetic keratitis or having diminished corneal sensation. * Patients with severe dry eye, apical corneal scarring, hydrops, a history of corneal surgery, or ophthalmic disease other than keratoconus. * Single eyed patients. * Patients on systemic treatment involving steroids or immune-compromised patients. * Patients who cannot be monitored with frequent visits as required in the study protocol. * Pregnant and nursing females.

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Conditions

The condition(s) this trial relates to.

corneal disorder Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cairo University Faculty of Medicine (Kasr Al Ainy)

    Cairo, Al-Manial, 11956, Egypt

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