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Incidence of Descemet Membrane Detachment Post GATT by AS OCT

Primary Purpose

Angle Glaucoma Open

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gonioscopy-Assisted Transluminal Trabeculotomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Angle Glaucoma Open focused on measuring gonioscopy-assisted transluminal trabeculotomy, Descemet membrane detachment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 - 70 years. Patients with open angle glaucoma undergoing gonioscopy assisted transluminal trabeculotomy. Exclusion Criteria: Patients with with open angle glaucoma and aphakia. Patients with Congenital Glaucoma. Patients with open angle glaucoma undergoing phaco -gonioscopy-assisted transluminal trabeculotomy. Patients with neovascular glaucoma. Patients with pigmentary Glaucoma.

Sites / Locations

  • Facility of medicine , Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GATT group

Arm Description

detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.

Outcomes

Primary Outcome Measures

Incidence of Descemet Membrane detachment post GATT
Incidence of Descemet membrane Detachment post Gonioscopy-Assisted Transluminal Trabeculotomy

Secondary Outcome Measures

Amount of reduction of IOP and Glaucoma NGM
Amount of reduction of intraocular pressure and Number of Glaucoma medications
Incidence of Hyphema post GATT
Incidence of Hyphema post Gonioscopy-Assisted Transluminal Trabeculotomy
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.

Full Information

First Posted
May 7, 2023
Last Updated
October 18, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05932940
Brief Title
Incidence of Descemet Membrane Detachment Post GATT by AS OCT
Official Title
Incidence of Descemet Membrane Detachment Post Gonioscopy-Assisted Transluminal Trabeculotomy by Anterior Segment Optical Coherence Tomography in Patients With Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
detection of Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Detailed Description
In our study, which should include 30 eyes with OAG who underwent 360 GATT Screening for Descemet Membrane Detachment will be done by Anterior Segment Optical coherence Tomography using SD-OCT: Optovue RTVue (Optovue Inc., Fremont, CA, USA) for the angle day 1 post operative for all patients and 1 week post operative in cases with Descemet membrane detachment to check for spontaneous resolution. One month post-operative the patients underwent Best corrected visual acuity (BCVA) using decimal. IOP measurement using GAT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle Glaucoma Open
Keywords
gonioscopy-assisted transluminal trabeculotomy, Descemet membrane detachment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GATT group
Arm Type
Experimental
Arm Description
detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Intervention Type
Procedure
Intervention Name(s)
Gonioscopy-Assisted Transluminal Trabeculotomy
Intervention Description
Ab interno angle surgery one of MIGS to lower IOP
Primary Outcome Measure Information:
Title
Incidence of Descemet Membrane detachment post GATT
Description
Incidence of Descemet membrane Detachment post Gonioscopy-Assisted Transluminal Trabeculotomy
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Amount of reduction of IOP and Glaucoma NGM
Description
Amount of reduction of intraocular pressure and Number of Glaucoma medications
Time Frame
4 months
Title
Incidence of Hyphema post GATT
Description
Incidence of Hyphema post Gonioscopy-Assisted Transluminal Trabeculotomy
Time Frame
4 months
Title
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Description
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 70 years. Patients with open angle glaucoma undergoing gonioscopy assisted transluminal trabeculotomy. Exclusion Criteria: Patients with with open angle glaucoma and aphakia. Patients with Congenital Glaucoma. Patients with open angle glaucoma undergoing phaco -gonioscopy-assisted transluminal trabeculotomy. Patients with neovascular glaucoma. Patients with pigmentary Glaucoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fayrouz Aboalazayem, phD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facility of medicine , Cairo University
City
Cairo
State/Province
Almanial
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Incidence of Descemet Membrane Detachment Post GATT by AS OCT

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