跳至主要内容
临床试验/CTRI/2025/10/096126
CTRI/2025/10/096126尚未招募2 期

Visual functions after early laser in Central Serous Chorioretinopathy

Hyderabad Eye Research Foundation, L V Prasad Eye Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1.Effect of laser on higher-order visual functions following fluid resolution.

研究概览

简要总结

•CSCR is a retinal disorder caused by choroidal vascular abnormalities, resulting in subretinal fluid (SRF) accumulation and disturbances in retinal pigment epithelium (RPE) function.

•Patients experience significant impairment in qualitative visual functions—such as contrast sensitivity, colour vision, and metamorphopsia—that can persist even after SRF resolution.

•Laser photocoagulation accelerates SRF resolution, but its role in preserving visual functions remains unclear.

•This study aims to investigate whether early laser photocoagulation in acute CSCR can mitigate the loss of qualitative visual functions compared to conventional observation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients presenting with first episode of acute CSCR as diagnosed on OCT with presence of subretinal fluid involving foveal centre with duration of symptoms less than 4 weeks will be included.

排除标准

  • SRF secondary to cause other than CSCR
  • History suggestive of previous episodes of CSCR (Also by clinical signs or investigations)
  • Presence of CNVM with CSCR
  • Hazy media due to cataracts/ any other cause not allowing detailed imaging
  • Previous history of Anti VEGF/ Laser photocoagulation
  • Presence of cystic macular edema or subretinal exudates associated ocular comorbidities
  • Any allergy/ systemic contraindication to use of FFA/ICGA dyes or laser.

结局指标

主要结局

1.Effect of laser on higher-order visual functions following fluid resolution.

时间窗: 2, 4 and 6 months

Key vision metrics analysed:

时间窗: 2, 4 and 6 months

2.BCVA

时间窗: 2, 4 and 6 months

3.Contrast Sensitivity

时间窗: 2, 4 and 6 months

Colour Vision

时间窗: 2, 4 and 6 months

4.Metamorphopsia

时间窗: 2, 4 and 6 months

5.Aniseikonia

时间窗: 2, 4 and 6 months

次要结局

  • Proportion of patients achieving fluid resolution in each arm.(Number of crossovers (patients transitioning from observation to laser).)

研究者

发起方
Hyderabad Eye Research Foundation, L V Prasad Eye Institute
申办方类型
Other [Non Profitable Organization]
责任方
Principal Investigator
主要研究者

DrRitesh Narula

L V Prasad Eye Institute

研究点 (1)

Loading locations...

相似试验