Primary Open Angle GlaucomaNCT06526416
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.
An observational study of Primary Open Angle Glaucoma and Glaucoma, run by Benha University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Open Angle Glaucoma, Glaucoma
- What is being tested?
- Anterior segment optical coherence tomography
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients presenting to Benha University Hospitals with open angle glaucoma.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anterior Chamber Angle Changes After Bent Angle Needle Goniectomy Procedure, Anterior Segment OCT Study
Evaluation of anterior segment using anterior segment optical coherence tomography in patients undergoing planned bent angle needle goniectomy procedure for uncontrolled open angle glaucoma.
- Conditions
- Primary Open Angle Glaucoma, Glaucoma
- Being tested
- Anterior segment optical coherence tomography
- Keywords
- Bent angle needle goniectomy, anterior segment optical coherence tomography, Primary open angle glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior segment optical coherence tomographyOther
Imaging of the anterior segment of the eye using optical coherence tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure.
Measured: 12 weeks after the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Hussein Fouad Hassan, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526416
- Sponsor's protocol ID
- RC.50.5.2023
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Chamber Angle Changes After Bent Angle Needle Goniectomy Procedure, Anterior Segment OCT Study
- ClinicalTrials.gov ID
- NCT06526416
- Acronym / sponsor ID
- RC.50.5.2023
- Conditions
- Primary Open Angle Glaucoma, Glaucoma
- Keywords
- Bent angle needle goniectomy, anterior segment optical coherence tomography, Primary open angle glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of anterior segment using anterior segment optical coherence tomography in patients undergoing planned bent angle needle goniectomy procedure for uncontrolled open angle glaucoma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients presenting to Benha University Hospitals with open angle glaucoma.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior segment optical coherence tomographyImaging of the anterior segment of the eye using optical coherence tomography | Other | – |
Primary outcome
To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy
Time frame: 12 weeks after the day of surgery.
To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy
1 secondary outcome
To detect any correlation between the post-op anterior chamber angle changes and the intraocular pressure.
Time frame: 12 weeks after the day of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma and Glaucoma, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A Awwad, MSc, MD, PhD (+201017014208, mohamed.awad@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect the changes in anterior chamber angle using Anterior segment OCT after BANG goniectomy (time frame: 12 weeks after the day of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.