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临床试验/NCT01982383
NCT01982383终止不适用

A Prospective Study of the Use of Micropulse 577nm Laser Treatment in Central Serous Chorioretinopathy

George Washington University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Resolution of Fluid Build-up

研究概览

简要总结

The investigators hypothesis is that using the micropulse laser in patient with Central Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in significantly minimizing visual recovery time from this disease as well as potentially preventing recurrences.

详细描述

The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity. This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment.

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
None

入排标准

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

入选标准

  • Patients with new diagnosis of CSC and no other comorbidities or prior retinal treatment
  • Patients ranging from 30 to 60 years of age

排除标准

  • Patients with no case of CSC
  • Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration
  • Patients with prior retinal treatment

研究组 & 干预措施

Micropulse Laser Treatment

Experimental

Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine

干预措施: Micropulse Laser Treatment (Device)

No Treatment

Placebo Comparator

Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending

干预措施: No treatment (Other)

结局指标

主要结局

Resolution of Fluid Build-up

时间窗: within 1 week to 3 months after the laser procedure is completed

Central Serous Choroidopathy is a disease that causes fluid to build up under the retina,the back part of the inner eye that sends sight information to the brain. The objective here is to apply 577nm of micropulse laser to see if CSC resolution occurs and measuring it through ocular coherence tomography (retinal imaging), vision score, and visual field testing for retinal sensitivity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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