NCT05932940

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

May 7, 2023

Last Update Submit

March 13, 2024

Conditions

Angle Glaucoma Open

Keywords

gonioscopy-assisted transluminal trabeculotomyDescemet membrane detachment

Outcome Measures

Primary Outcomes (1)

  • Incidence of Descemet Membrane detachment post GATT

    Incidence of Descemet membrane Detachment post Gonioscopy-Assisted Transluminal Trabeculotomy

    4 months

Secondary Outcomes (3)

  • Amount of reduction of IOP and Glaucoma NGM

    4 months

  • Incidence of Hyphema post GATT

    4 months

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

    4 months

Study Arms (1)

GATT group

EXPERIMENTAL

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

Interventions

Gonioscopy-Assisted Transluminal TrabeculotomyPROCEDURE

Ab interno angle surgery one of MIGS to lower IOP

GATT group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 70 years.
  • Patients with open angle glaucoma undergoing gonioscopy assisted transluminal trabeculotomy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility of medicine , Cairo University

Cairo, Almanial, Egypt

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Fayrouz Aboalazayem, phD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Opthalmology resident Cairo University

Study Record Dates

First Submitted

May 7, 2023

First Posted

July 6, 2023

Study Start

December 1, 2022

Primary Completion

March 1, 2024

Study Completion

May 10, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)