NCT06526416

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

July 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 22, 2024

Last Update Submit

July 26, 2024

Conditions

Keywords

Bent angle needle goniectomyanterior segment optical coherence tomographyPrimary open angle glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure.

    12 weeks after the day of surgery.

Interventions

Imaging of the anterior segment of the eye using optical coherence tomography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients presenting to Benha University Hospitals with open angle glaucoma.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Mohammed A Awwad, MSc, MD, PhD

CONTACT

Nader H.F Hassan, MSc, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Ophthalmology

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 29, 2024

Study Start

November 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 29, 2024

Record last verified: 2024-07