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RecruitingNCT07454447Updated Mar 6, 2026

UBM Evaluation After Combined Deep Sclerectomy With Trabeculotomy in Primary Open Angle Glaucoma

An observational study in Primary Open Angle Glaucoma (POAG), sponsored by Minia University Hospital. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Minia University Hospital · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Sex
All
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Study 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. 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.

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Conditions studied

  • Primary Open Angle Glaucoma (POAG)

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Keywords

  • Primary Open Angle Glaucoma
  • Deep Sclerectomy
  • Trabeculotomy
  • Ultrasoun Biomicroscopy
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In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 30 is below the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Minia University Hospital is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 obtained from the patient .

Exclusion criteria

Exclusion Criteria:

  • 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: Ultrasound Biomicroscopy

Interventions

  • Diagnostic testUltrasound Biomicroscopy

    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.

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What researchers measure

Primary outcomes

  1. Intrascleral lake area on ultrasound biomicroscopy (UBM)

    Quantitative measurement of intrascleral lake area (mm²) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.

    Time frame: 3 and 6 months postoperatively

  2. Intrascleral lake height on ultrasound biomicroscopy (UBM)

    Quantitative measurement of intrascleral lake height (mm) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.

    Time frame: 3 and 6 months postoperatively

  3. Filtering bleb height on ultrasound biomicroscopy (UBM)

    Quantitative measurement of filtering bleb height (mm) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.

    Time frame: 3 and 6 months postoperatively

  4. 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.

    Time frame: 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.

    Time frame: 3 and 6 months postoperatively

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07454447
Lead sponsor
Minia University Hospital
Responsible party
Ahmed Magdy Farouk Mohamed (MSc Candidate in Ophthalmology, Minia University Hospital) — Principal investigator
First posted
Mar 6, 2026
Start date
Nov 11, 2025
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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