Intraluminal Stenting Versus External Ligation of Ahmed Glaucoma Valve
NCT04508881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2020-08-11
Summary
Objectives: To compare the intraluminal stenting and external ligation of Ahmed Glaucoma Valve (AGV) regarding refractory glaucoma management and postoperative hypotony prevention.
Patients and Methods: This randomized clinical trial included 30 eyes of 25 patients (age range: 44-56 y) with refractory glaucoma. This study was conducted during the period from September 2018 to January 2020. The study included two groups, AGV with intraluminal stenting group (n=15) and AGV with external ligation group (n=15). Follow up continued to a year post operation. The primary outcome was Intraocular pressure (IOP) and its association with the number of postoperative glaucoma medications. IOP ≤ 21 mmHg without medications announced complete success while IOP ≤ 21 mmHg with medications indicated qualified success. IOP of \<6 mmHg defined hypotony.
Key Words: Stenting- ligation- Ahmed valve- Hypotony
Conditions
Interventions
- DEVICE
-
Ahmed Glaucoma Valve
To compare the prevalence of postoperative hypotony between the 2 arms
Sponsors & Collaborators
-
Mansoura University
collaborator OTHER -
Menoufia University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 44 Years
- Max Age
- 56 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-12
- Primary Completion
- 2020-01-10
- Completion
- 2020-01-13
Countries
- Egypt
Study Locations
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