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Fixating the Plate of Ahmed Valve to the Sclera Using a Flanged Prolene Suture

NCT ID: NCT06722794

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-10-31

Brief Summary

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this study evaluated new technique for suturing the Ahmed valve device used to treat resistant types of glaucoma

Detailed Description

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This technique of fixating Ahmed glaucoma valve using flanged prolene suture is an safe, fast, and reproducible technique combines the benefits of fixing the plate with excellent stability with no complications of free plate techniques at the same time, decreasing both the risks of old valve plate fixation techniques and the concerns of the relative technical difficulty

Conditions

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Glaucoma

Keywords

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Ahmed glaucoma valve, prolene, glaucoma drainage device

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene S

Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture

Group Type OTHER

Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture

Intervention Type PROCEDURE

This novel technique of fixating the plate of Ahmed glaucoma valve to the sclera using a single flanged prolene suture is an efficient, safe, fast, and reproducible technique that combines the benefits of both fixing the plate providing excellent stability without the complications of free plate techniques and at the same time, minimizing both the risks of conventional old valve plate fixation techniques and the concerns of the relative technical difficulty of suturing due to the difficult access to the posterior globe

Interventions

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Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture

This novel technique of fixating the plate of Ahmed glaucoma valve to the sclera using a single flanged prolene suture is an efficient, safe, fast, and reproducible technique that combines the benefits of both fixing the plate providing excellent stability without the complications of free plate techniques and at the same time, minimizing both the risks of conventional old valve plate fixation techniques and the concerns of the relative technical difficulty of suturing due to the difficult access to the posterior globe

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with IOP more than 21 mmHg , evidence of progressive optic nerve damage, retinal nerve fiber layer defects or typical glaucomatous visual field defects despite maximal tolerable medical or laser treatment are scheduled for surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Magrabi Eye & Ear Hospital

OTHER

Sponsor Role collaborator

Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AHMED SAMIR, MD

Role: PRINCIPAL_INVESTIGATOR

ZAGAZIG UNIVERSITY AND MAGHRABI EYE HOSPITALS

Locations

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Maghrabi Eye Hospitals

Jeddah, Jedda, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Maghrabi eye hospitals

Identifier Type: OTHER

Identifier Source: secondary_id

MEH-IRB# 310- 1-October-2024

Identifier Type: -

Identifier Source: org_study_id