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

Ultrasound Biomicroscopy 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.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma (POAG)
• Intervention / Treatment: Diagnostic test: Ultrasound Biomicroscopy

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Egypt
  • Minya Governorate
    • Minya, Minya Governorate, Egypt
      • Recruiting
      • Minia University Hospital
      • Contact: Ahmed Magdy Farouk, MD; Phone Number: +201551416518; Email: ahmed.magdy1077@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intraocular pressure	Change in intraocular pressure (mmHg) from baseline to 3 and 6 months after combined deep sclerectomy with trabeculotomy.	3 and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Minia University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Primary Open Angle Glaucoma; Trabeculotomy; Deep Sclerectomy; Ultrasoun Biomicroscopy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography; Microscopy; Microscopy, Acoustic
• Other Study ID Numbers: MUFMIRB-1766-11-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No