Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hôpital Privé de la Baie
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Intraocular pressure measure
概览
简要总结
Pseudoexfoliative glaucoma is a glaucoma secondary to pseudoexfoliative syndrome; cataract surgery is often more difficult, with more complications. Tran's cannula is a single-use irrigation system designed for cleaning, with the pseudoexfoliative material remaining in the trabecular meshwork.
The main objective of this study is to evaluate the efficacy of the Tran cannula, in comparison with increased irrigation, in lowering intraocular pressure (IOP) in patients with pseudoexfoliative glaucoma and treated for glaucoma, and with an indication for isolated cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cataract and early-to-moderate pseudoexfoliative glaucoma (GPX) scheduled for isolated cataract surgery.
- •Reliable visual field, Humphrey 24-2, Sita-Fast, with typical glaucoma alterations, and with mean deviation ≤-12 dB.
- •OCT with ganglion cell alterations and fibers typical of glaucoma.
- •Typical glaucomatous neuropathy
- •Slit-lamp signs of pseudoexfoliation.
- •Open angle (2 to 4, according to Shaffer classification) determined by gonioscopy.
- •Untreated eye pressure \>21 mmHg and \<33 mmHg
排除标准
- •Presence of other ophthalmological pathologies (except cataract or mild dry eye)
- •History of intraocular surgery in the last 12 months, history of trauma
- •History of laser trabeculoplasty (TLA or SLT) in the previous 12 months
- •Visual acuity below "finger count
- •Myopia ≥ 6 dioptres, hyperopia ≥ 5 dioptres
- •Iridocorneal angle closure (and angle-closure glaucoma), any other type of non-pseudoexfoliative glaucoma, iris neovascularization
- •Pachymetry \< 490 μm or \> 620 μm; or corneal pathology or other condition that makes accurate IOP measurements with flattening tonometry, ultrasonic pachymetry or specular microscopy impossible.
- •Presence of severe systemic pathologies
研究组 & 干预措施
augmented irrigation surgery
Patients treated with augmented irrigation cannula.
干预措施: augmented irrigation (Procedure)
Tran cannula surgery
Patients treated with Tran cannula
干预措施: Tran canula (Procedure)
结局指标
主要结局
Intraocular pressure measure
时间窗: day 1, day 30, month 3, month 6 and month 12 after surgery
次要结局
未报告次要终点