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临床试验/NCT01020071
NCT01020071已完成不适用

Prospective Evaluation of the Efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty: A Pilot Study

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
The primary outcome measures are the intraocular pressure difference pre and post laser and the opening of angles.

研究概览

简要总结

Objective: The main objective of this study is to evaluate the efficacy of Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty in lowering intraocular pressure and opening up the angles in patients with narrow angles, primary angle closure and primary angle closure glaucoma.

The specific objectives are to evaluate the pain and inflammation associated with the procedure and its possible adverse effects on the lens and corneal endothelium.

Study Design: Prospective, interventional case series Study Population: Healthy males and females with appositional angle closure aged 21 y/o and above Methods: Potential participants are evaluated by a glaucoma specialist in National University Hospital. If they are identified as having appositional angle closure they are invited to participate in the study and assigned to either iridotomy or iridoplasty depending on the mechanism of angle closure present. Pupil block for Pascal Laser Iridotomy and plateau iris and angle crowding for Pascal Laser Peripheral Iridoplasty. If they agree to participate they will undergo visual acuity, slit lamp examination, intraocular pressure determination by Goldmann Applanation Tonometry, gonioscopy, optic nerve head evaluation by indirect ophthalmoscopy and lens evaluation by LOCS III opacity grading system. Humphrey visual field examination using 24-2 SITA standard algorithm and stereodisc photos will be obtained if not done within the past 12 months. Anterior segment OCT and laser flare meter will also be performed prior to the procedure. Enrolled patients will be divided into 2 groups. The first group will be assigned to Pascal Laser Iridotomy. The primary mechanism of angle closure in this group is pupillary block. The second group will be assigned to Pascal Laser Peripheral Iridoplasty. This group has non-pupil bock mechanisms which include plateau iris or angle crowding. After the laser procedure, follow-up examinations will be done 1 hr post laser, 1 week, 1 month, 3 months and 6 months.

Outcome Measures: The primary outcome measures are the intraocular pressure difference pre and post laser and the opening of angles. Secondary outcome measures are pain and inflammation associated with laser procedure, lens and corneal endothelial changes.

详细描述

PLANNED INTERVENTIONS Potential study participants are seen by a glaucoma specialist at National University Hospital. If they are identified as having primary angle closure and have met the inclusion criteria mentioned above, they will be invited to participate in the study. Potential risks and benefits will be explained. After which, they will sign an informed consent when they agree to participate.

Visual acuity, slit lamp examination, intraocular pressure determination through Goldmann Applanation Tonometry, gonioscopy, optic nerve head examination through indirect ophthalmoscopy and lens evaluation using LOCS III lens opacity grading system will be done on baseline visit. Humphrey visual field exam using 24-2, SITA standard algorithm and stereodisc photos will also be obtained if not done within the past 12 months. Anterior segment OCT, laser flare meter of the anterior chamber and corneal endothelial cell count will also be done.

Based on gonioscopy and anterior segment OCT findings, the primary mechanism of angle closure will be analyzed. Depending on the major mechanism, they will be assigned to either Pascal Laser Iridotomy and Pascal Laser Peripheral Iridoplasty. Patients identified as having pupil block will be assigned to Pascal Laser Iridotomy and those identified as having plateau iris configuration, plateau iris syndrome or angle crowding will be assigned to Pascal Laser Peripheral Iridoplasty.

Post laser follow up will be done after 1 week, 1 month, 3 months and 6 months.

PASCAL LASER IRIDOTOMY Prior to laser procedure 1 drop each of Alphagan-P and 4% Pilocarpine are instilled 15 minutes prior.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy males and females having 2 sighted eyes aging 21 y/o and above
  • primary angle closure with pupil block component
  • plateau iris syndrome or plateau iris configuration
  • occludable angles 180 deg and above
  • have uncontrolled IOP (>21 mmHg)
  • able to follow up
  • able to give informed consent

排除标准

  • advanced visual field defect affecting 10 degrees of fixation
  • previous ocular surgeries
  • advanced corneal edema or opacification
  • flat anterior chamber
  • synechially closed angles
  • coexisting ocular pathology except cataract

结局指标

主要结局

The primary outcome measures are the intraocular pressure difference pre and post laser and the opening of angles.

时间窗: 6 months

次要结局

  • Secondary outcome measures are pain and inflammation associated with laser procedure, lens and corneal endothelial changes.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ophthalmology

Associate Professor Paul Chew

National University Hospital, Singapore

研究点 (2)

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