Angle Closure: Laser Iridotomy Versus Phacoemulsification Study (ACLIPS)- A Study of Acute Primary Angle Closure Glaucoma Comparing Two Treatment Modalities: Laser Peripheral vs Phacoemulsification With Posterior Intraocular Lens Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- IOP lowering medication is required.
研究概览
简要总结
This is a randomised controlled clinical trial to compare laser peripheral iridotomy (LPI) and primary phacoemulsification with intra-ocular lens implantation (phaco/IOL) in the treatment of acute primary angle-closure glaucoma (APACG). Following successful medical lowering of raised intra-ocular pressure (IOP) and control of intraocular inflammation, patients presenting to Singapore National Eye Centre and Singapore General Hospital with acute primary angle-closure glaucoma who meet the eligibility are randomised to one of the two treatment arms: laser peripheral iridotomy and primary phacoemulsification with intra-ocular lens implantation. These patients will be monitored closely for 2 years post-operatively.
详细描述
AIMS
The objective of this study is to conduct a randomised controlled clinical trial to compare LPI and primary phacol/IOL in the treatment of APACG.
The specific aim is to compare long-term IOP control in patients who undergo LPI with patients who undergo primary phaco/IOL. At the same time the following will be studied.
- To evaluate the safety of these two techniques for the treatment of APACG
- To assess the development of PAS
- To establish if LPI and primary phaco/IOL are as effective in preventing the recurrence of acute attack in eyes with APACG
TREATMENT PLAN
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
- None
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
- •APACG. In cases where both eyes are eligible, the right eye will be entered.
- •IOP less than or equal to 30 mmHg within 24 hours of presentation and after initiation of medical treatment
- •Significant cataract with best corrected visual acuity equal or less than 6/15
- •Informed consent
排除标准
- •Secondary causes of angle-closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
- •Intumescent cataract (phacomorphic glaucoma)
- •Eyes with anterior chamber depth differing by more than 0.3 mm
- •Eyes with no cataract
- •Active ocular infection in either eye which would prevent surgery
- •Female subjects who are pregnant, nursing or of childbearing potential and not using adequate contraception
- •Participating in another study
- •Previous intraocular eye surgery on the affected eye.
- •Any medical condition which would be a contra-indication to surgery
结局指标
主要结局
IOP lowering medication is required.
Recurrence of APACG: Patients who develop a recurrence of symptoms of APACG. Treatment of recurrence will be decided by the ophthalmologist managing the patient.
Further glaucoma surgery is required.
次要结局
- Eyes become phthisical
- Cataract surgery is required. Patients in the LPI group who develop significant progression of cataract during the follow-up period will be offered cataract extraction.
- No light perception