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临床试验/NCT05230355
NCT05230355已完成不适用

Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Assiut University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
IOP reduction success rate

研究概览

简要总结

The aim of this study is to assess the results of subliminal subthreshold transscleral diode cyclophotocoagulation in refractory glaucoma using the standard technique of 360 degree application and to compare the outcome with a modified technique both in terms of efficacy and safety.

详细描述

Refractory glaucoma is glaucoma that doesn't respond favorably to surgical and/or medical treatment to lower intraocular pressure. It can include primary open angle glaucoma, primary angle closure glaucoma, neovascular glaucoma or silicone oil-induced glaucoma. Cyclophotocoagulation (CPC) is a form of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. Transscleral cyclophotocoagulation using a continuous diode laser has been a treatment option in advanced glaucoma cases with s¬¬uboptimal IOP control, for a long time. High treatment energy used by diode laser cyclophotocoagulation was argued to be associated with increased frequency of serious complications such as vision loss, hypotony, and phthisis. These concerns necessitate modulation of the parameters of laser treatment used.

Micropulse transscleral cyclophotocoagulation (MP-TSCPC), which is a variation of conventional continuous-wave CPC, has emerged as an attractive alternative for the treatment of many types of glaucoma. It breaks the continuous wave laser into multiple short and repetitive pulses that allow the tissue to cool down between applications, thus reducing thermal damage. This strategy delivers very short energy pulses followed by rest periods, which is known as "duty cycle" and is defined as the ratio of time that a laser is delivering energy vs resting (ON/OFF). For this procedure, an infrared diode laser is used to stimulate the ciliary body structures and the uveoscleral pathway. This way it reduces the production of the aqueous humour and facilitates the uveoscleral outflow, with IOP reduction as a final effect.

Despite promising results, only few clinical studies are published on MP-TSCPC and most of them are retrospective studies refer to patients having previous continuous wave transscleral cyclophotocoagulation. Moreover, Several parameters and protocols have been studied in other reports in an attempt to refine the standard technique aiming to improve the outcomes without increasing the adverse effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •patients with refractory glaucoma (IOP > 21 mmHg unresponsive to maximally tolerated antiglaucoma medications, previously failed surgical treatment, or both)

排除标准

  • •Ocular inflammation.
  • •Ocular infection.
  • •Recent ocular surgery in the study eye in the 2 months prior to enrolment.

研究组 & 干预措施

group A the standard technique

Active Comparator

The tip of the probe was moved in a "painting" motion along the upper and lower hemispheres over pars plana, 3 mm behind the limbus, avoiding the 3 and 9 o'clock positions.

干预措施: standard technique (Device)

Group B a modified technique

Active Comparator

The probe tip was moved for 2 mm perpendicular to a line 3 mm parallel to the cornea, aiming to cover the largest circumference of the ciliary body area.

干预措施: modified pattern (Device)

结局指标

主要结局

IOP reduction success rate

时间窗: 6 months

Success rate is defined as achieving an IOP between 5 and 21 mmHg or at least a 20% reduction in IOP at the final follow up with or without IOP lowering medications

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

Mohamed Omar

Assistant lecturer of ophthalmology

Assiut University

研究点 (1)

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