Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 9:51 PM
Study NCT ID:
NCT05797350
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2023-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
Sponsor:
Al Watany Eye Hospital
Organization:
Study Overview
Official Title:
Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
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:
A randomized controlled trial comparing the efficacy and safety of Paul glaucoma implant and Ahmed glaucoma valve in refractory childhood glaucoma patients
Detailed Description:
A prospective randomized controlled trial was conducted at Al Watany Eye Hospital in Egypt. Patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either Paul or Ahmed glaucoma drainage devices.
Patients will be followed up for at least one year during which the following data are collected.
Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded
Patients will be followed up for at least one year during which the following data are collected.
Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded
Study Oversight
Has Oversight DMC:
True
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?: