Incidence of Descemet Membrane Detachment Post GATT by AS OCT

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05932940

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Angle Glaucoma Open	Procedure: Gonioscopy-Assisted Transluminal Trabeculotomy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Diagnostic

Official Title:

Incidence of Descemet Membrane Detachment Post Gonioscopy-Assisted Transluminal Trabeculotomy by Anterior Segment Optical Coherence Tomography in Patients With Open Angle Glaucoma

Actual Study Start Date :

Dec 1, 2022

Actual Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GATT group detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.	Procedure: Gonioscopy-Assisted Transluminal Trabeculotomy Ab interno angle surgery one of MIGS to lower IOP

Arm

Intervention/Treatment

Experimental: GATT group

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

Procedure: Gonioscopy-Assisted Transluminal Trabeculotomy

Ab interno angle surgery one of MIGS to lower IOP

Outcome Measures

Primary Outcome Measures

Incidence of Descemet Membrane detachment post GATT [4 months]
Incidence of Descemet membrane Detachment post Gonioscopy-Assisted Transluminal Trabeculotomy

Secondary Outcome Measures

Amount of reduction of IOP and Glaucoma NGM [4 months]
Amount of reduction of intraocular pressure and Number of Glaucoma medications
Incidence of Hyphema post GATT [4 months]
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. [4 months]
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Facility of medicine , Cairo University	Cairo	Almanial	Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Fayrouz Aboalazayem, phD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Elsayed Soliman Ahmed, Opthalmology resident Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT05932940

Other Study ID Numbers:

MS-275-2022

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marwa Elsayed Soliman Ahmed, Opthalmology resident Cairo University, Cairo University

gonioscopy-assisted transluminal trabeculotomy

Descemet membrane detachment

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Jul 6, 2023