Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers

Phase 4

Not yet recruiting

• Conditions: Neurotrophic Keratopathy
• Interventions: Drug: insulin eye drops

• Registration Number: NCT06331910
• Lead Sponsor: Assiut University

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).

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 Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Study Start: 2024-04-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
insulin eye drop	insulin eye drops	-

Primary Outcome Measures

Name	Time	Method
Decrease in ulcer size and the increase in visual acuity .	baseline	To evaluate the effect of topical insulin eye drops in treatment of neurotrophic corneal ulcer.