Treatment Trial for Acute Central Serous Chorioretinopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy

Conditions
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Acute Central Serous Chorioretinopathy

Intervention / Treatment
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* Device: 577-MPL
* Device: 577-TL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 577-MPL<br>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. | Device: 577-MPL<br>* All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the<br>|
| Active Comparator: 577-TL<br>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. | Device: 577-TL<br>* All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-TL arm. 100 microns light spot size, 0.05 seconds duration, 80   200 milliwatts of power<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of eyes with complete absorption of subretinal fluid (SRF) | 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) | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Best Corrected Visual Acuity (BCVA) |  | 1months,3 months and 6 months | 
| Change of fundus autofluorescence | Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment | 1months,3 months and 6 months | 
| Change in 10° retinal sensitivity |  | baseline,1months,3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CSC, Micropulse Laser, Traditional Laser