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临床试验/NCT05299281
NCT05299281已完成不适用

Micropulse Transscleral Diode Laser Cyclophotocoagulation (MP-TSCPC) as a Treatment Modality for Glaucoma Patients

Benha University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020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
入组人数
40
试验地点
2
主要终点
Intraocular pressure (IOP)

研究概览

简要总结

The study objective was to evaluate the efficacy and safety of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.

详细描述

Evaluation of the efficacy and safety of a new form of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.

In this study, 810 nm infrared diode laser radiation in the micro- pulse mode was used in conjunction with a G probe (IRIDEX Medical Instruments, Mountain View, CA, USA).

The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser set on micro- pulse mode, delivered over 100-200 seconds (envelope of micropulses) depending on severity of the case and other patient factors. With duty cycle 31.3% (This translates to 0.5 ms "on" time and 1.1 ms "off" time), which allows the tissue to cool down between laser shots, thus greatly reducing thermal damage.

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
None

入排标准

年龄范围
3 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients previously diagnosed with glaucoma if they had uncontrolled Intraocular pressure despite maximal tolerated medical therapy.
  • Patients who are unable to maintain compliance with the prescribed topical medications.
  • Patients who need filtering glaucoma surgery for controlling Intraocular pressure but are not generally fit for the surgery.
  • Patients who refused incisional procedures like subscleral trabeculectomy.

排除标准

  • Patients who were unable to give informed consent.
  • Patients who had undergone previous conventional transscleral diode laser cyclophotocoagulation (TSCPC).
  • Patients with significant scleral thinning defined as thinning of more than one clock hour noticed on scleral transillumination.
  • Patients with ongoing ocular infection or inflammation.

结局指标

主要结局

Intraocular pressure (IOP)

时间窗: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

significant change in IOP in mmHg.

best corrected visual acuity (BCVA)

时间窗: Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively

change in BCVA using snellen's chart

次要结局

  • complication rate.(Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively)
  • change in number of postoperative glaucoma medications.(Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively)
  • retreatment rate.(Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively)

研究者

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

Gehad Hassan Abdelhalim Mohamed Youssef

Assisstant lecturer of ophthalmology

Benha University

研究点 (2)

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