Intraluminal Stenting Versus External Ligation of Ahmed Glaucoma Valve

NCT04508881 | Completed

• 2 other identifiers: Faried1976Tharwat Mokbel
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Postoperative hypotony

  by measuring intraocular poressure postoperatively by Goldmann Applanation tonometer

  1 year

Secondary Outcomes (2)

• postoperative hypertensive phase by Goldmann Applanation tonometer

  1 year

• low Complications

  1 year

Study Arms (2)

External ligation

ACTIVE COMPARATOR

External ligation of the valve tube by vicryl sutures

Device: Ahmed Glaucoma Valve

intraluminal stenting

ACTIVE COMPARATOR

stenting of the valve tube by prolene suture

Device: Ahmed Glaucoma Valve

Interventions

Ahmed Glaucoma Valve DEVICE

To compare the prevalence of postoperative hypotony between the 2 arms

External ligation; intraluminal stenting

Eligibility Criteria

• Age: 44 Years - 56 Years
• Gender Eligibility Details: based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• eyes of 25 patients (age range: 44-56 y) with refractory glaucoma

You may not qualify if:

• other types of glaucoma

Sponsors & Collaborators

• Menoufia University: lead
• Mansoura University: collaborator

Study Sites (1)

Faried Wagdy

Cairo, Menofia, Egypt

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Ophthalmolgy- Menoufia hospital

Model Details: : 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.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 11, 2020
• Study Start: September 12, 2018
• Primary Completion: January 10, 2020
• Study Completion: January 13, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)