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Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06331910
Enrollment
14
Registered
2024-03-26
Start date
2024-04-01
Completion date
2025-05-01
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurotrophic Keratopathy

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.

Interventions

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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 * Leprosy * Trigeminal neuralgia surgery

Exclusion criteria

* Non compliant patients with the study protocol

Design outcomes

Primary

MeasureTime frameDescription
Decrease in ulcer size and the increase in visual acuity .baselineTo evaluate the effect of topical insulin eye drops in treatment of neurotrophic corneal ulcer.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026