NCT04562402Unknown不适用
Phacoemulsification With Endoscopic Cyclophotocoagulation vs Phacoemulsification Alone in Primary Angle Closure (PHEPHA): A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
Comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens.
详细描述
The purpose of our current randomized clinical trial is to compare phacoemulsification with endoscopic cyclophotocoagulation (PHE) versus phacoemulsification alone (PHA) in patients with either primary angle closure (PAC) or primary angle closure glaucoma (PACG) presenting with cataract or a clear lens.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is above 40 years old.
- •A diagnosis of either PAC or PACG. PAC will be defined as the presence of irido-trabecular contact on gonioscopy, either appositional or in the presence of peripheral anterior synechiae (PAS), without indentation (or prior documentation before a LPI has been performed) without any evidence of glaucomatous optic neuropathy. PACG will be defined as PAC along with an evidence of glaucomatous optic neuropathy. An optic neuropathy secondary to glaucoma will be defined as evidence of structural and functional damage suggestive of glaucoma as demonstrated by clinical examination, optical coherence tomography, and visual field testing.
- •IOP measurement that is more than 21 mmHg (not exceeding 35 mmHg) without the use of glaucoma medications or less than 21 mmHg with medications.
- •Patient is able to give an informed consent and tolerate a period of medication washout.
排除标准
- •Previous intraocular surgery (including CPC). Glaucoma laser procedures are allowed (e.g. LPI, iridoplasty, and laser trabeculoplasty).
- •Previous ocular trauma.
- •A central corneal thickness that does not lie between 500 and 600 microns.
- •A diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm).
- •Presence of pseudoexfoliation.
- •Presence of secondary causes of angle closure such as neovascular glaucoma and uveitic glaucoma.
- •Presence of diabetic retinopathy (active PDR or active DME) or agerelated macular degeneration. PHEPHA Protocol Version 2 September 3, 2020
- •Advanced glaucoma as defined by the Glaucoma Severity Staging System12 (mean deviation worse than -12.01 dB and at least one of the following:
- •On pattern deviation plot, greater than or equal to 50% but fewer than 75% of points depressed below the 5% level and greater than or equal to 25% but fewer than 50% of points depressed below 1% level
- •Any point within central 5 degrees with sensitivity < 0db
- •Both hemifields containing a point(s) with sensitivity < 15 dB within 5 degrees of fixation).
- •Any ocular or systemic condition that is presumed to prevent reliable clinical examination and/or visual field testing.
- •Inability to attend postoperative follow ups for a period of 12 months after surgery.
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 12 months
Change in IOP between baseline (pre-intervention) and the last follow-up visit
Number of glaucoma medications
时间窗: 12 months
Change in the number of glaucoma medications between baseline (pre-intervention) and the last follow-up visit
次要结局
未报告次要终点
研究者
Adi Al Owaifeer, MBBS
Consultant
King Khaled Eye Specialist Hospital
研究点 (2)
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