The Objective is to Evaluate the Anterior Chamber Angle A... | NCT06526416

Studies
The Objective is to Evaluate the Anterior Chamber Angle After BANG Procedure, the Study Will Recruit 12 Patients Who Will Undergo Planned Goniectomy for Uncontrolled POAG, Anterior Segment OCT Scan Will Be Used to Evaluate the Anterior Chamber Postoperatively.

NCT06526416

Sponsor

Benha University

Status

Not yet recruiting

Last Update Posted

Jul 29, 2024Actual

Enrollment

12Estimated

Phase

Not provided

Conditions

Primary Open Angle Glaucoma
Glaucoma

Interventions

Anterior segment optical coherence tomography

Countries

Not provided

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

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Jul 22, 2024

First Submission Date that Met QC Criteria

Jul 26, 2024

First Posted Date

Jul 29, 2024Actual

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

Jul 26, 2024

Last Update Posted Date

Jul 29, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of anterior segment using anterior segment optical coherence tomography in patients undergoing planned bent angle needle goniectomy procedure for uncontrolled open angle glaucoma.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anterior segment optical coherence tomography	Other	Imaging of the anterior segment of the eye using optical coherence tomography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy	To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy	12 weeks after the day of surgery.

Secondary Outcomes

Measure	Description	Time Frame
To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure.	To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure.	12 weeks after the day of surgery.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are being treated for primary open angle glaucoma using eye drops.
Patients with uncontrolled intraocular pressure >21 mm Hg
All recruited patients should have open anterior chamber angles demonstrated on gonioscopy examination.
Patients giving consent for operation and follow up

Exclusion Criteria:

1- Pseudophakic patients 2- Advanced glaucoma patients. 3- Patients who are to have trabeculectomy or laser trabeculoplasty. 4- Patients with secondary glaucoma. 5- Patients who are unable to give consent for surgery or follow up. 6- Patients with previous trauma to the eye

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients presenting to Benha University Hospitals with open angle glaucoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammed A Awwad, MSc, MD, PhD	Contact	+201017014208		mohamed.awad@fmed.bu.edu.eg
Nader H.F Hassan, MSc, MD, PhD	Contact	+201224727982		naderhf@fmed.bu.edu.eg

Overall Officials

Not provided

Locations

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma