Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Central Serous Chorioretinopathy
- Sponsor
- Jin Chen-jin
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- the proportion of eyes with complete absorption of subretinal fluid (SRF)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jin Chen-jin
Dr
Sun Yat-sen University
Eligibility Criteria
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
- •inability to obtain photographs or to perform FA
- •use of steroid systemically or topically in the last 6 months
Outcomes
Primary Outcomes
the proportion of eyes with complete absorption of subretinal fluid (SRF)
Time Frame: 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 Outcomes
- Change of Best Corrected Visual Acuity (BCVA)(1months,3 months and 6 months)
- Change of fundus autofluorescence(1months,3 months and 6 months)
- Change in 10° retinal sensitivity(baseline,1months,3 months and 6 months)