Treatment Trial for Acute Central Serous Chorioretinopathy
- Conditions
- Acute Central Serous Chorioretinopathy
- Interventions
- Device: 577-MPLDevice: 577-TL
- Registration Number
- NCT02784665
- Lead Sponsor
- Jin Chen-jin
- Brief Summary
Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger patients. It is characterized by serous detachment of the neurosensory retina with or without serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be treated with traditional laser photocoagulation, but it has the side effects of causing RPE atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment but it's more than most families can afford to pay because of the high cost, what's more, it is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium (RPE) atrophy and RPE rip.
To date there is no international consensus on the optimal treatment of CSC Many retrospective studies suggest that micropulse laser (MPL) therapy may also be effective without obvious complications in this disease.
The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute central serous chorioretinopathy compared with the traditional laser coagulation.
- Detailed Description
The study is a prospective randomized controlled trial about 577nm micropulse laser versus traditional laser coagulation therapy on acute central serous chorioretinopathy. The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid 3 months after treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- onset for the first time, as an episode duration of less than 6 months
- patient was between 18 and 55 years of age
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
- active fluorescein leakage during fluorescein angiography (FA)
- best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
- previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
- other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
- retinal atrophy
- pregnancy
- inability to obtain photographs or to perform FA
- use of steroid systemically or topically in the last 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 577-MPL 577-MPL 577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area. 577-TL 577-TL 577nm Traditional laser(577-TL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Traditional laser spots will be applied, covering the leakage area.
- Primary Outcome Measures
Name Time Method the proportion of eyes with complete absorption of subretinal fluid (SRF) 3 month The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)
- Secondary Outcome Measures
Name Time Method Change of Best Corrected Visual Acuity (BCVA) 1months,3 months and 6 months Change of fundus autofluorescence 1months,3 months and 6 months Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment
Change in 10° retinal sensitivity baseline,1months,3 months and 6 months
Trial Locations
- Locations (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China