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临床试验/NCT04912362
NCT04912362Unknown不适用

Effectiveness of YAG Laser Iridotomy in Preventing Peripheral Anterior Synechia After CO2 Laser-Assisted Sclerectomy Surgery in Primary Open Angle Glaucoma

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Intraocular pressure

研究概览

简要总结

To investigate the effectiveness of YAG laser iridotomy in preventing peripheral anterior synechia after CO2 Laser-Assisted Sclerectomy Surgery and the long-term effect of reducing intraocular pressure

详细描述

Group A: YAG laser iridotomy was performed one week before operation, followed by CO2 Laser-Assisted Sclerectomy Surgery; Group B: only CO2 Laser-Assisted Sclerectomy Surgery; The patients were followed up for 1 year to observe and compare the difference of the incidence of peripheral anterior synechia and the effect of long-term intraocular pressure control between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Primary open angle glaucoma patients in Ophthalmic Center;
  • Topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control;
  • The patients were 18 to 50 years old, regardless of gender;
  • Class operation was performed;
  • Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
  • Informed consent has been signed.

排除标准

  • Allergic to any perioperative medication in this study;
  • History of ocular trauma;
  • Any previous intraocular surgery;
  • Gonioscopy showed a narrow angle (Schaffer III or below);
  • Secondary glaucoma was diagnosed;
  • Optic atrophy caused by other reasons;
  • Severe complications such as rupture of posterior capsule and choroidal hemorrhage occurred during operation;
  • Patients with severe ocular complications after operation
  • The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
  • Women in pregnancy, lactation or planned pregnancy;
  • The researchers believe that the patient's condition may put the patient at significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.

结局指标

主要结局

Intraocular pressure

时间窗: 1 year

Intraocular pressure

Peripheral anterior synechia

时间窗: 1 year

Incidence of peripheral anterior synechia

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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