Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy

Официальное название

Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy: A Case Series Study

Обзор

This study aims to investigate the clinical characteristics of pigmentary glaucoma and evaluate the efficacy and safety of ab-interno 120° trabeculotomy during the 6-month postoperative follow-up period.

Подробное описание

This is a single-center, retrospective case series study. Patients with pigmentary glaucoma treated at Zhongnan Hospital of Wuhan University will be enrolled. By systematically collecting their baseline demographic characteristics, ocular examination results, and prior treatment history, the study aims to summarize the distribution pattern of clinical features of pigmentary glaucoma. With the 6-month postoperative follow-up as the primary endpoint, the study will evaluate the intraocular pressure-lowering effect of ab-interno 120° trabeculotomy, changes in medication dependence, and the stability of visual field and retinal nerve fiber layer, while observing the occurrence of related intraoperative and postoperative complications, so as to provide clinical evidence for individualized surgical treatment of pigmentary glaucoma.

Вмешательства

• Процедура Ab-interno 120° Trabeculotomy
  A minimally invasive glaucoma surgery (MIGS) procedure performed via an ab interno approach, involving a 120-degree incision of the trabecular meshwork to improve aqueous humor outflow.

Первичные конечные точки

• Change in Intraocular Pressure (IOP) at 6 Months Postoperatively [Срок оценки: 6 months postoperatively]
• Change in the Number of Intraocular Pressure-Lowering Medications at 6 Months [Срок оценки: 6 months postoperatively]

Вторичные конечные точки (6)

• Changes in Visual Field Parameters at 6 Months Postoperatively [Срок оценки: 6 months postoperatively]
• Changes in Visual Field Parameters at 6 Months Postoperatively [Срок оценки: 6 months postoperatively]
• Changes in Visual Acuity at 6 Months Postoperatively [Срок оценки: 6 months postoperatively]
• Status of Trabeculotomy Site on Gonioscopy [Срок оценки: 6 months postoperatively]
• Improvement in Pupillary Block and Iris Configuration [Срок оценки: 6 months postoperatively]
• Rate of Secondary Glaucoma Surgery [Срок оценки: From the day of surgery to 6 months postoperatively]

Критерии участия

Критерии включения

• Meet the clinical diagnostic criteria for pigmentary glaucoma, with typical signs of pigment dispersion syndrome, extensive trabecular meshwork pigmentation, pathological intraocular pressure elevation, glaucomatous optic nerve damage, and characteristic visual field defects;
• Underwent primary isolated ab-interno 120° trabeculotomy as the initial surgical treatment;
• Have complete preoperative and postoperative examination data, including slit-lamp biomicroscopy, gonioscopy, intraocular pressure, visual field, and OCT RNFL measurements;
• Able to complete regular follow-up for at least 6 months postoperatively.

Критерии исключения

• Patients with exfoliation syndrome, exfoliative glaucoma, or other types of primary or secondary glaucoma;
• Patients with a history of ocular trauma, intraocular surgery, uveitis, severe retinopathy, or other ocular diseases affecting intraocular pressure and visual function assessment;
• Patients who underwent combined procedures such as concurrent cataract surgery or other anti-glaucoma surgeries during the operation;
• Patients with severe systemic diseases, cognitive or psychiatric disorders that prevent cooperation with examinations and follow-up;
• Patients with missing key clinical or follow-up data that preclude efficacy and prognosis evaluation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Zhongnan Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT07713056 · 20260523

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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