Incidence of Descemet Membrane Detachment Post GATT by AS... | NCT05932940

Studies
Incidence of Descemet Membrane Detachment Post GATT by AS OCT

NCT05932940

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 15, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Angle Glaucoma Open

Interventions

Gonioscopy-Assisted Transluminal Trabeculotomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Mar 1, 2024Actual

Completion Date

May 10, 2024Estimated

First Submitted Date

May 7, 2023

First Submission Date that Met QC Criteria

Jul 3, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Gonioscopy-Assisted Transluminal Trabeculotomy	Procedure	Ab interno angle surgery one of MIGS to lower IOP	GATT group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Descemet Membrane detachment post GATT	Incidence of Descemet membrane Detachment post Gonioscopy-Assisted Transluminal Trabeculotomy	4 months

Secondary Outcomes

Measure	Description	Time Frame
Amount of reduction of IOP and Glaucoma NGM	Amount of reduction of intraocular pressure and Number of Glaucoma medications	4 months
Incidence of Hyphema post GATT	Incidence of Hyphema post Gonioscopy-Assisted Transluminal Trabeculotomy

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fayrouz Aboalazayem, phD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Facility of medicine , Cairo University		Cairo	Almanial		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

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Browse Branches

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