Intraluminal Stenting Versus External Ligation of Ahmed Glaucoma Valve

NCT04508881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-08-11

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508881 on ClinicalTrials.gov