Primary Open Angle Glaucoma (POAG)NCT07454447
UBM Evaluation After Combined Deep Sclerectomy With Trabeculotomy in Primary Open Angle Glaucoma
An observational study of Primary Open Angle Glaucoma (POAG), run by Minia University Hospital at 1 site in Egypt.
Trial summary
Primary open-angle glaucoma is a chronic optic neuropathy that often requires surgical intervention when medical treatment fails. Deep sclerectomy is a non-penetrating glaucoma surgery that aims to reduce intraocular pressure while minimizing complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG)
- What is being tested?
- Ultrasound Biomicroscopy
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 diagnosed with primary open-angle glaucoma (POAG), including juvenile open-angle glaucoma (JOAG), who underwent combined deep sclerectomy with trabeculotomy at Minia University Hospital. All included eyes were followed postoperatively using ultrasound biomicroscopy (UBM) to evaluate intrascleral lake and filtering bleb morphology at defined follow-up intervals.
Who may be able to join
- Diagnosis of primary open-angle glaucoma (POAG), including juvenile open-angle glaucoma (JOAG).
- Patients who underwent combined deep sclerectomy with trabeculotomy.
- Clear media allowing adequate ultrasound biomicroscopy imaging.
- Written informed consent obtained from the patient .
Who cannot join
- Secondary glaucomas (e.g., neovascular, uveitic, traumatic, or angle-closure glaucoma).
- Previous glaucoma filtering surgery in the studied eye.
- Coexisting ocular pathology affecting UBM assessment (e.g., severe corneal opacity, scleral pathology).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya, Minya Governorate
Ahmed Magdy Farouk, MD, +201551416518, ahmed.magdy1077@gmail.com
About this study
Official title: Ultrasound Biomicroscopy Evaluation After Combined Deep Sclerectomy With Trabeculotomy in Primary Open Angle Glaucoma
Primary open-angle glaucoma is a chronic optic neuropathy that often requires surgical intervention when medical treatment fails. Deep sclerectomy is a non-penetrating glaucoma surgery that aims to reduce intraocular pressure while minimizing complications. When combined with trabeculotomy, additional aqueous outflow may be achieved.
Ultrasound biomicroscopy (UBM) allows detailed imaging of the anterior segment and provides valuable information about postoperative anatomical changes that cannot be assessed clinically. This observational study aims to evaluate UBM findings after combined deep sclerectomy with trabeculotomy in patients with primary open-angle glaucoma and to correlate these findings with clinical outcomes.
Read the detailed description
This is a prospective observational study conducted at Minia University Hospital on patients diagnosed with primary open-angle glaucoma who underwent combined deep sclerectomy with trabeculotomy. Patients are evaluated postoperatively using ultrasound biomicroscopy to assess anterior segment structures, including the intrascleral lake, filtering bleb characteristics, and trabeculo-Descemet membrane.
Clinical parameters such as intraocular pressure, number of antiglaucoma medications, and postoperative outcomes are recorded and correlated with UBM findings. The study aims to identify anatomical predictors of surgical success and to enhance understanding of postoperative changes following combined non-penetrating glaucoma surgery.
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Being tested
- Ultrasound Biomicroscopy
- Keywords
- Primary Open Angle Glaucoma, Deep Sclerectomy, Trabeculotomy, Ultrasoun Biomicroscopy
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound BiomicroscopyDiagnostic test
Ultrasound biomicroscopy is performed as a non-invasive diagnostic imaging procedure to evaluate postoperative anterior segment anatomy, including intrascleral lake characteristics and filtering bleb morphology, in patients with primary open-angle glaucoma following combined deep sclerectomy with trabeculotomy.
| Study group | Role | What they receive |
|---|---|---|
| POAG post-combined deep sclerectomy with trabeculotomy | Patients with primary open-angle glaucoma who underwent combined deep sclerectomy with trabeculotomy. Postoperative assessment is performed using ultrasound biomicroscopy to evaluate intrascleral lake characteristics, filtering bleb morphology, and related anatomical parameters. Receives: Diagnostic Test: Ultrasound Biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrascleral lake area on ultrasound biomicroscopy (UBM)
Quantitative measurement of intrascleral lake area (mm²) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
Measured: 3 and 6 months postoperatively
Intrascleral lake height on ultrasound biomicroscopy (UBM)
Quantitative measurement of intrascleral lake height (mm) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
Measured: 3 and 6 months postoperatively
Filtering bleb height on ultrasound biomicroscopy (UBM)
Quantitative measurement of filtering bleb height (mm) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
Measured: 3 and 6 months postoperatively
Filtering bleb internal reflectivity on ultrasound biomicroscopy (UBM)
Semi-quantitative assessment of filtering bleb internal reflectivity on ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
Measured: 3 and 6 months postoperatively
Secondary outcomes (1)
Change in intraocular pressure
Change in intraocular pressure (mmHg) from baseline to 3 and 6 months after combined deep sclerectomy with trabeculotomy.
Measured: 3 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start11 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (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 Glaucoma (POAG)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Farouk Mohamed, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454447
- Sponsor's protocol ID
- MUFMIRB-1766-11-2025
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Biomicroscopy Evaluation After Combined Deep Sclerectomy With Trabeculotomy in Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07454447
- Acronym / sponsor ID
- MUFMIRB-1766-11-2025
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Keywords
- Primary Open Angle Glaucoma, Deep Sclerectomy, Trabeculotomy, Ultrasoun Biomicroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 2026 (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.
Primary open-angle glaucoma is a chronic optic neuropathy that often requires surgical intervention when medical treatment fails. Deep sclerectomy is a non-penetrating glaucoma surgery that aims to reduce intraocular pressure while minimizing complications. When combined with trabeculotomy, additional aqueous outflow may be achieved.
Ultrasound biomicroscopy (UBM) allows detailed imaging of the anterior segment and provides valuable information about postoperative anatomical changes that cannot be assessed clinically. This observational study aims to evaluate UBM findings after combined deep sclerectomy with trabeculotomy in patients with primary open-angle glaucoma and to correlate these findings with clinical outcomes.
Detailed description
This is a prospective observational study conducted at Minia University Hospital on patients diagnosed with primary open-angle glaucoma who underwent combined deep sclerectomy with trabeculotomy. Patients are evaluated postoperatively using ultrasound biomicroscopy to assess anterior segment structures, including the intrascleral lake, filtering bleb characteristics, and trabeculo-Descemet membrane.
Clinical parameters such as intraocular pressure, number of antiglaucoma medications, and postoperative outcomes are recorded and correlated with UBM findings. The study aims to identify anatomical predictors of surgical success and to enhance understanding of postoperative changes following combined non-penetrating glaucoma surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POAG post-combined deep sclerectomy with trabeculotomy | – | Diagnostic Test: Ultrasound BiomicroscopyPatients with primary open-angle glaucoma who underwent combined deep sclerectomy with trabeculotomy. Postoperative assessment is performed using ultrasound biomicroscopy to evaluate intrascleral lake characteristics, filtering bleb morphology, and related anatomical parameters. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with primary open-angle glaucoma (POAG), including juvenile open-angle glaucoma (JOAG), who underwent combined deep sclerectomy with trabeculotomy at Minia University Hospital. All included eyes were followed postoperatively using ultrasound biomicroscopy (UBM) to evaluate intrascleral lake and filtering bleb morphology at defined follow-up intervals.
Key inclusion criteria (4 listed)
- Diagnosis of primary open-angle glaucoma (POAG), including juvenile open-angle glaucoma (JOAG).
- Patients who underwent combined deep sclerectomy with trabeculotomy.
- Clear media allowing adequate ultrasound biomicroscopy imaging.
- Written informed consent obtained from the patient .
Key exclusion criteria (3 listed)
- Secondary glaucomas (e.g., neovascular, uveitic, traumatic, or angle-closure glaucoma).
- Previous glaucoma filtering surgery in the studied eye.
- Coexisting ocular pathology affecting UBM assessment (e.g., severe corneal opacity, scleral pathology).
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 |
|---|---|---|
| Ultrasound BiomicroscopyUltrasound biomicroscopy is performed as a non-invasive diagnostic imaging procedure to evaluate postoperative anterior segment anatomy, including intrascleral lake characteristics and filtering bleb morphology, in patients with primary open-angle glaucoma following combined deep sclerectomy with trabeculotomy. | Diagnostic test | POAG post-combined deep sclerectomy with trabeculotomy |
Primary outcome
Intrascleral lake area on ultrasound biomicroscopy (UBM)
Time frame: 3 and 6 months postoperatively
Quantitative measurement of intrascleral lake area (mm²) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
Intrascleral lake height on ultrasound biomicroscopy (UBM)
Time frame: 3 and 6 months postoperatively
Quantitative measurement of intrascleral lake height (mm) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
Filtering bleb height on ultrasound biomicroscopy (UBM)
Time frame: 3 and 6 months postoperatively
Quantitative measurement of filtering bleb height (mm) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
Filtering bleb internal reflectivity on ultrasound biomicroscopy (UBM)
Time frame: 3 and 6 months postoperatively
Semi-quantitative assessment of filtering bleb internal reflectivity on ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.
1 secondary outcome
Change in intraocular pressure
Time frame: 3 and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma (POAG), run by Minia University Hospital at 1 site in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrascleral lake area on ultrasound biomicroscopy (UBM) (time frame: 3 and 6 months postoperatively). The study lists 4 primary outcomes in all. 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 6 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.