Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331910
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-15
Brief Title:
Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Topical Insulin in Treatment of Neurotrophic Corneal UlcerEfficacy And Safety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 stainthe increase in visual acuity
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 stainthe increase in visual acuity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None