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Recruiting NCT07454447

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

— Observational Primary Open Angle Glaucoma (POAG)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound Biomicroscopy.
Who it may be relevant to
Registry conditions: Primary Open Angle Glaucoma (POAG). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test Ultrasound 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.

Primary outcome measures

  • Intrascleral lake area on ultrasound biomicroscopy (UBM) [Time frame: 3 and 6 months postoperatively]
  • Intrascleral lake height on ultrasound biomicroscopy (UBM) [Time frame: 3 and 6 months postoperatively]
  • Filtering bleb height on ultrasound biomicroscopy (UBM) [Time frame: 3 and 6 months postoperatively]
  • Filtering bleb internal reflectivity on ultrasound biomicroscopy (UBM) [Time frame: 3 and 6 months postoperatively]
Secondary outcome measures (1)
  • Change in intraocular pressure [Time frame: 3 and 6 months postoperatively]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Minia University Hospital — Minya

Identifiers

NCT: NCT07454447 · MUFMIRB-1766-11-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗