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临床试验/CTRI/2024/01/061667
CTRI/2024/01/061667已完成不适用

Relationship Between Iris Thickness and Angle Opening After Laser Peripheral Iridotomy in Primary Angle Closure Disease: An AS OCT Study

Sankara Eye Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
1. To correlate variations in iris thickness with variations in angle opening post iridotomy.

研究概览

简要总结

This study is an observational, single arm, follow up study investigating the relationship between iris thickness and angle opening following laser peripheral iridotomy in patients diagnosed with primary angle closure disease using Anterior Segment Optical Coherence Tomography. The primary objectives are to correlate the variations in iris thickness with variations in angle opening post iridotomy, and to assess the impact of baseline iris morphology on post iridotomy outcomes. These will be assessed at follow ups of one week and six months after the advised procedure of laser iridotomy. The secondary objective is to analyse the effect and amount of angle opening after iridotomy at the end of six months.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Confirmed diagnosis of Primary Angle Closure Disease based on clinical evaluation and diagnostic tests.
  • Willing and able to provide informed consent for AS OCT imaging.
  • Ability to cooperate with imaging procedure AS OCT.

排除标准

  • Patients with secondary cause of angle closure.
  • Patients requiring peripheral iridotomy augmentation.
  • Patients with plateau iris syndrome.
  • Presence of corneal abnormalities that may interfere with the AS OCT imaging.
  • Eyes with incomplete laser peripheral iridotomy perforation.
  • Use of topical or systemic medications that could affect the anterior chamber.
  • History of ocular trauma or surgery within the past 6 months.
  • Pregnancy or breastfeeding in female participants.

结局指标

主要结局

1. To correlate variations in iris thickness with variations in angle opening post iridotomy.

时间窗: 1. By comparing the iris thickness at various distances to angle opening distance and trabecular iris angle at pre-treatment, post one week and post 6 months of treatment. | 2. To compare the pre-treatment iris thickness at various distance to the angle opening distance and trabecular iris angle at one week and six months post treatment.

2. To assess the impact of baseline iris morphology on post iridotomy outcomes.

时间窗: 1. By comparing the iris thickness at various distances to angle opening distance and trabecular iris angle at pre-treatment, post one week and post 6 months of treatment. | 2. To compare the pre-treatment iris thickness at various distance to the angle opening distance and trabecular iris angle at one week and six months post treatment.

次要结局

  • To analyse the effect of angle opening after iridotomy at the end of 6 months(6 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Meghana Mulpuri

Sankara Eye Hospital

研究点 (1)

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