Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294015
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-31
Brief Title:
Efficacy of 20 Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Efficacy of 20 Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
Introduction Glaucoma is the second leading cause of blindness globally Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium with up to 78 of treated patients reporting dry eye symptoms Autologous serum eye drops ASED contains essential growth factors and nutrients which may promote corneal and conjunctival integrity offering benefits over traditional treatments This study investigates the efficacy of 20 ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops
Methods The present study is a triple-blinded randomized controlled trial that anticipates to enroll 25 patients 50 eyes with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months in addition to standard artificial tears treatment
The primary outcome is the comparison of National Eye Institute NEI scores between autologous serum drops and placebo-treated eyes at two months Secondary outcomes include Schirmers test scores visual acuity tear break-up time TBUT Ocular Surface Disease Index OSDI scores intraocular pressure and complication rates
The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients potentially offering a new therapeutic avenue
Methods The present study is a triple-blinded randomized controlled trial that anticipates to enroll 25 patients 50 eyes with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months in addition to standard artificial tears treatment
The primary outcome is the comparison of National Eye Institute NEI scores between autologous serum drops and placebo-treated eyes at two months Secondary outcomes include Schirmers test scores visual acuity tear break-up time TBUT Ocular Surface Disease Index OSDI scores intraocular pressure and complication rates
The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients potentially offering a new therapeutic avenue
Detailed Description:
None
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