Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers

March 24, 2024 updated by: Gehad Abd Elrahim Ahmed, Assiut University

Topical Insulin in Treatment of Neurotrophic Corneal Ulcer,Efficacy And Safety

To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Neurotrophic keratopathy is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation. A reduction In corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing epithelial keratopathy, ulceration and perforation.

Because decreased corneal sensitivity is the hallmark sign of neurotrophic keratitis (NK), corneal sensitivity testing should be performed as soon as It is suspected

There are 2 common ways to test-one qualitative, the other quantitative:

The qualitative method is most commonly used In clinic and often achieved with a cotton tipped applicator because It is easily accessible.

The most common quantitative method is the handheld esthesiometer (Cochet-Bonnet).

Standard treatment of neurotrophic corneal ulcer involves aggressive lubrication of the corneal surface, therapeutic contact lenses, amniotic membrane grafts and tarsorrhaphy . Refractory neurotrophic corneal ulcers occur when treatment response is incomplete and are potentially blinding.

Insulin is a widely available, relatively safe, and familiar medication that has been shown to improve corneal epithelial healing In vitro and in diabetic animal models. However, clinical experience with topical insulin in patients with non-healing corneal wounds is minimal.

Insulin-like growth factor-1 (IGF-1) has been shown to be an important modulator of corneal wound healing.

Topical insulin may be a simple and effective treatment for neurotrophic corneal ulcers.

The main outcome measurements for improvement are the decrease of ulcer size by fluroscien stain,the increase in visual acuity.

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 4

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with neurotrophic corneal ulcers caused by:

    • Herpes simplex or Herpes zoster viral infection
    • Topical anesthetics abuse
    • Chemical and physical burn
    • Chronic CL wear
    • Following LASIK,PRK,CXL
    • Following vitrectomy and endophotocoagulation for retinal detachment
    • Diabetes mellitus
    • Leprosy
    • Trigeminal neuralgia surgery

Exclusion Criteria:

  • Non compliant patients with the study protocol

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: insulin eye drop
Drug: insulin eye drops
Insulin eye drops deliver insulin directly to the cornea, They exploit insulin's ability to stimulate cell growth, potentially reducing healing time with minimal side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in ulcer size and the increase in visual acuity .
Time Frame: baseline
To evaluate the effect of topical insulin eye drops in treatment of neurotrophic corneal ulcer.
baseline

Collaborators and Investigators

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

Sponsor

Assiut 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TITNCUES

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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