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Clinical Trials/NCT06331910
NCT06331910Not yet recruitingPhase 4

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

Assiut University0 sites14 target enrollmentStarted: April 1, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
14
Primary Endpoint
Decrease in ulcer size and the increase in visual acuity .

Study Overview

Brief Summary

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

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • Trigeminal neuralgia surgery

Exclusion Criteria

  • Non compliant patients with the study protocol

Arms & Interventions

insulin eye drop

Experimental

Intervention: insulin eye drops (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gehad Abd Elrahim Ahmed

Doctor

Assiut University

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