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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMinia University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: POAG post-combined deep sclerectomy with trabeculotomy1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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