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临床试验/NCT04410861
NCT04410861Unknown不适用

Comparison of Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy

Moorfields Eye Hospital Centre Abu Dhabi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Change in Best-Corrected Visual Acuity (BCVA)

研究概览

简要总结

Central serous retinopathy is a disease of poorly understood etiology characterized by accumulation of subretinal fluid and leading to significant decrease in vision. Micropulse laser therapy has been successfully used in the treatment of CSR of both acute and chronic types (1). In this treatment invisible, non-damaging laser shots are delivered to the affected area which are believed to lead to absorption of accumulated fluid. The mechanism of fluid resorption is unclear. There are several treatment protocols in place (2, 3). Most commonly reported are minimal protocol and so-called panmacular protocol. However, there is no comparative study between them assessing their clinical efficacy.

The purpose of this trial is to compare treatment efficacy in central serous chorioretinopathy (CSR) using two laser parameter settings. Those will include minimal and panmacular protocols. Two wavelengths will be used 577nm and 810 nm for which the rest of the parameters will be defined in order to produce sublethal photostimulation. Structural and functional outcomes will be compared before and after treatment as well as measures such as number of repeat treatments or need for rescue treatment. We aim to show which of the laser arms will lead to better clinical outcomes.

详细描述

Study Design:

This is a comparative, prospective, interventional, multicenter, randomized study of micropulse laser treatment of central serous chorioretinopathy with 2 treatment arms:

  1. < 6 months. Treatment: Minimal vs. Panmacular (randomized)
  2. > 6 months. Treatment: Panmacular only

Treatment arms - description of laser settings:

For "Minimal / PLACE" treatment (Mainster contact lens with magnification of 1.05x):

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 (Care Provider)

入排标准

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

入选标准

  • •CSR diagnosed < 6 months ago Willingness to undergo micropulse laser treatment and keep follow-up visits

排除标准

  • •High myopia Other significant macular disease, other treatment for CSR Pregnancy

研究组 & 干预措施

Minimal Micropulse Arm

Active Comparator

Wavelength 810 577 Power 0.75 W 0.15 W DC 5% 5% Spot size 125um 100um Duration 0.3 sec 0.3 sec Number of spots 100-120 100-120

.

干预措施: Micropulse laser photostimulation (Procedure)

Panmacular Micropulse Arm

Experimental

Wavelength 810 577 Power 1.7 W 0.425 W DC 5% 5% Spot size 500um 500um Duration 0.3 sec 0.3 sec Number of spots 400-450 400-450

干预措施: Micropulse laser photostimulation (Procedure)

结局指标

主要结局

Change in Best-Corrected Visual Acuity (BCVA)

时间窗: 6 months

BCVA will be measured using ETDRS charts and number of letters will be compared before treatment and during follow-up and at the last visit.

Resolution of Subretinal Fluid

时间窗: 6 months

This outcome will be assessed by optical coherence tomography (OCT). Microns of central retinal thickness will be compared before treatment and during follow-up and at the last visit. The presence/absence of subretinal fluid will be recorded.

次要结局

  • Visual Field Examination(6 months)
  • Need for Re-treatment(6 months)

研究者

发起方
Moorfields Eye Hospital Centre Abu Dhabi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Igor Kozak

Consultant Vitreoretinal Surgeon/Clinical Lead

Moorfields Eye Hospital Centre Abu Dhabi

研究点 (1)

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