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NCT Number: NCT07454447

UBM 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.

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Key information

Conditions

Primary Open Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Minia University Hospital

Minya, Minya Governorate, Egypt

Location status: Recruiting

Location contact

Ahmed Magdy Farouk, MD

CONTACT

[email protected]

+201551416518

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent obtained from the patient .

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).

Treatment and study plan

Ultrasound Biomicroscopy

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in intraocular pressure

    Time frame: 3 and 6 months postoperatively

    Change in intraocular pressure (mmHg) from baseline to 3 and 6 months after combined deep sclerectomy with trabeculotomy.

Sponsors and collaborators

Lead sponsor

Minia University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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