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

December 6, 2024 updated by: Zagazig University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jedda, Saudi Arabia, 22230
        • Maghrabi Eye Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Exclusion Criteria:

  • The exclusion criteria were as follows: patients below 18 years old, those with active uveitis and angle closure glaucoma patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long term stability and plate migration
Time Frame: 3 months
ABSENT MOVEMENT OF THE PLATE WITH NO OTHER COMPLICATIONS
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Collaborators

Magrabi Eye & Ear Hospital

Investigators

  • Principal Investigator: AHMED SAMIR, MD, ZAGAZIG UNIVERSITY AND MAGHRABI EYE HOSPITALS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEH-IRB# 310- 1-October-2024
  • Maghrabi eye hospitals (Other Identifier: Maghrabi eye hospitals)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

PERSONAL REASONS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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