跳至主要内容
临床试验/NCT07454447
NCT07454447招募中不适用

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

Minia University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Intrascleral lake area on ultrasound biomicroscopy (UBM)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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 .

排除标准

  • 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).

研究组 & 干预措施

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.

干预措施: Ultrasound Biomicroscopy (Diagnostic Test)

结局指标

主要结局

Intrascleral lake area on ultrasound biomicroscopy (UBM)

时间窗: 3 and 6 months postoperatively

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

Intrascleral lake height on ultrasound biomicroscopy (UBM)

时间窗: 3 and 6 months postoperatively

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

Filtering bleb height on ultrasound biomicroscopy (UBM)

时间窗: 3 and 6 months postoperatively

Quantitative measurement of filtering bleb height (mm) using ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.

Filtering bleb internal reflectivity on ultrasound biomicroscopy (UBM)

时间窗: 3 and 6 months postoperatively

Semi-quantitative assessment of filtering bleb internal reflectivity on ultrasound biomicroscopy after combined deep sclerectomy with trabeculotomy.

次要结局

  • Change in intraocular pressure(3 and 6 months postoperatively)

研究者

发起方
Minia University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Magdy Farouk Mohamed

MSc Candidate in Ophthalmology

Minia University Hospital

研究点 (1)

Loading locations...

相似试验