Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy: A Case Series Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP) at 6 Months Postoperatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Intraocular Pressure (IOP) at 6 Months Postoperatively
时间窗: 6 months postoperatively
Change in intraocular pressure from baseline to 6 months after ab-interno 120° trabeculotomy, including the mean IOP level, absolute reduction, and percentage reduction relative to baseline.
Change in the Number of Intraocular Pressure-Lowering Medications at 6 Months
时间窗: 6 months postoperatively
Change in the number of glaucoma medications used by patients, comparing baseline to 6 months after surgery.
次要结局
- Changes in Visual Field Parameters at 6 Months Postoperatively(6 months postoperatively)
- Changes in Visual Acuity at 6 Months Postoperatively(6 months postoperatively)
- Status of Trabeculotomy Site on Gonioscopy(6 months postoperatively)
- Improvement in Pupillary Block and Iris Configuration(6 months postoperatively)
- Rate of Secondary Glaucoma Surgery(From the day of surgery to 6 months postoperatively)