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临床试验/NCT01758237
NCT01758237已完成不适用

Incidence of Visual Symptom Following Laser (Nd:YAG ) Peripheral Iridotomy (LPI) in Relation to Position of LPI

Credit Valley EyeCare2 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
214
试验地点
2
主要终点
Presence of Linear Dysphotopsia

研究概览

简要总结

To establish the correlation of the location of the Nd:YAG laser peripheral iridotomy to the post operative visual symptoms experienced by some patients. The investigators hypothesize that fully uncovered laser peripheral iridotomy will produce less significant dysphotopsia, due to avoidance of the prismatic effect produced by the tear film than those covered.

详细描述

Nd:YAG LPI is a frequently performed procedure for patients who have narrow angles at risk of acute angle closure glaucoma, pupillary-block conditions, chronic angle closure, and pigment dispersion syndrome. Most complications associated with the procedure are benign and include intraocular pressure (IOP) spike, transient uveitis, hyphema, corneal or lens damage and closure of the iridotomy. Visual disturbances have been also reported but only a few papers address this specific issue. The rate of these symptoms vary between 2.7% and 4%. It is believed that these symptoms are associated with the fact that light enters through the LPI and thus creating abnormal visual symptoms. Hence it has been suggested to carefully place the LPI so that the eyelid fully covers the LPI, therefore preventing light getting through. However, reports of patients with fully covered LPIs and visual disturbances have led to hypothesize the theory that even when fully covered by the eyelid, light can access through the LPI by a base-up prism created by the tear meniscus at the lid margin. Therefore, placement of the LPI, fully covered, partially covered or totally uncovered can potentially lead to equally significant symptoms. This study will attempt to address the issue of placement of the LPI in relationship with visual symptoms.

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

入选标准

  • Able and willing to make the required study visit
  • Able and willing to give consent and follow study instructions
  • An indication to undergo laser peripheral iridotomy (narrow angles, occludeable angle at risk of acute angle closure, pupil block condition, chronic angle closure, pigment dispersion syndrome)

排除标准

  • Previous intraocular surgery
  • Best corrected visual acuity worse than 20/40
  • Asymmetrical ptosis of more than 2mm
  • Any active intraocular inflammation
  • Acute attack of angle closure glaucoma

结局指标

主要结局

Presence of Linear Dysphotopsia

时间窗: Baseline (Time =0),1 month

The change in presence of linear dysphotopsia from baseline (prior to intervention) to 1 month after the Nd:YAG laser intervention is performed.

次要结局

  • Presence of Visual Dysphotopsia(Baseline (Time = 0), 1 month)
  • Pain Experienced(Procedure (Time = 0))
  • Nd:YAG Laser Power Used(Procedure (Time = 0))

研究者

发起方
Credit Valley EyeCare
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Iqbal Ike Ahmed

Principle Investigator

Credit Valley EyeCare

研究点 (2)

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