跳至主要内容
临床试验/NCT06099041
NCT06099041撤回不适用

ND-YAG Laser Iris Depigmentation for Cosmoses

Sohag University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
60
试验地点
1
主要终点
Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation

研究概览

简要总结

Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study

详细描述

Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study safety will be assessed by measuring IOP using Goldman applanation tonometry pre and post-session.

visual acuity assessment in Log-Mar pre and post-session. Refraction assessment pre and post-session. Lens and fundus assessments on slit-lamp and using auxiliary lens 78D

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • clear cornea
  • clear lens
  • normal IOP < 20 mmHg
  • adults aged more than 18 years old
  • normal fundus
  • dark pigmented iris (black or brown)

排除标准

  • Glaucomatous patients and those receiving anti-glaucoma treatment.
  • corneal or lens opacity.
  • any fundus abnormality

结局指标

主要结局

Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation

时间窗: one year

Session of Nd-YAG Laser targeting the iris using power less than that used for peripheral iridotomy causing pigment bleaching to change the iris colour for cosmoses, which may cause pigmentary glaucoma (secondary open angle glaucoma).

Safety of ND-YAG Laser, by visual acuity assessment in log-mar subjectively by using Snellen chart before and after ND-YAG Laser

时间窗: one year

If ND-YAG LASER could affect visual acuity.

次要结局

未报告次要终点

研究者

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

Elshimaa A.Mateen

Clinical professor

Sohag University

研究点 (1)

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