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临床试验/NCT02199158
NCT02199158已完成不适用

Short-term Outcomes of Iridoplasty for Persistent Angle Closure Despite Patent Iridotomies An Anterior Segment Optical Coherence Tomography Study

Instituto de Oftalmología Fundación Conde de Valenciana2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年7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
10
试验地点
2
主要终点
Angle Aperture

研究概览

简要总结

Purpose:

To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to report its complications at 1-week and 1-month follow up in patients that did not achieve a satisfactory clinical angle opening despite patent laser peripheral iridotomy.

Design:

Prospective, Interventional case series

Subjects:

Patients with an occludable angle in more than two quadrants in dark room indentation gonioscopy and patent iridotomies of at least 2 weeks, with assessment of persistent angle closure aetiology by ultrabiomicroscopy and A-scan ultrasound are included.

Patients will undergo complete examination and AS-OCT before ALPI, one week and one month after it. We analyzed the images in a masked manner and took the angle measurements (AOD500, AOD 750, TISA500, TISA750, ARA500, ARA 750, Lens vault) at 0° and 180° as the main outcome measure to determine effectiveness.

详细描述

Background Argon laser peripheral iridoplasty (ALPI) (Figure 1) is an iris-remodeling procedure that intends to widen the iridocorneal angle through redistribution of peripheral iris tension forces close to the trabeculum.

ALPI is effective in patients with plateau iris syndrome and acute angle closure glaucoma but there is less published about its effectiveness in secondary angle closure. Therefore, we are going to evaluate this procedure in those patients that did not achieve a satisfactory clinical angle opening despite patent laser peripheral iridotomy, as long as there was no contraindication for a new laser procedure and provided that cataract surgery is not viable, as in clear lens or patients not willing to undergo surgery.

To evaluate its effectiveness, we will use a non-invasive non-contact method through anterior segment optical coherence tomography (AS-OCT), which transmits and receives light in an ultrasound-like manner to obtain anterior segment imaging that helps to evaluate the angle more objectively.

Purpose To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to report its complications at 1-week and 1-month follow up in patients with persistent angle closure despite patent iridotomies.

Study Design Prospective, interventional case series Patients with an occludable angle in more than two quadrants in dark room dynamic gonioscopy and patent iridotomies of at least 2 weeks were included. A supplemental diagnosis regarding the etiology of persistent angle closure by ultrabiomicroscopy and A-scan ultrasound will be obtained. Patients who presented with these criteria to the angle closure clinic at the glaucoma service of our institute (Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City) between July and November 2012 were included.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (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

入选标准

  • Patients with an occludable angle in more than two quadrants in dark room dynamic gonioscopy and patent iridotomies of at least 2 weeks were included
  • A supplemental diagnosis regarding the etiology of persistent angle closure by ultrabiomicroscopy and A-scan ultrasound was obtained.

排除标准

  • Patients with synechiae of more than one quadrant
  • Advanced glaucomatous damage
  • Prompt cataract surgery plans and those who did not wish to participate were excluded

结局指标

主要结局

Angle Aperture

时间窗: 1 month

Angle opening measured by anterior segment optical coherence tomography

次要结局

  • Complications(1 month)

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (2)

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