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

NCT07454447 | Recruiting

• 1 other identifier: MUFMIRB-1766-11-2025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

Primary Open Angle Glaucoma; Deep Sclerectomy; Trabeculotomy; Ultrasoun Biomicroscopy

Outcome Measures

Primary Outcomes (4)

• Intrascleral lake area on ultrasound biomicroscopy (UBM)

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

  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.

  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.

  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.

  3 and 6 months postoperatively

Secondary Outcomes (1)

• Change in intraocular pressure

  3 and 6 months postoperatively

Study Arms (1)

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

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.

POAG post-combined deep sclerectomy with trabeculotomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 .

You may not qualify if:

• 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).

Sponsors & Collaborators

• Minia University Hospital: lead

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Microscopy, Acoustic

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Candidate in Ophthalmology

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: March 6, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)