Clinical trial NCT02784665: Treatment Trial for Acute Central Serous Chorioretinopathy
Official title: Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Central Serous Chorioretinopathy
Keywords: CSC
Micropulse Laser
Traditional Laser
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. onset for the first time, as an episode duration of less than 6 months
2. patient was between 18 and 55 years of age
3. the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
4. active fluorescein leakage during fluorescein angiography (FA)
5. best corrected visual acuity (BCVA) more than 0.1, and less than 1.0

Exclusion Criteria:

1. previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
2. other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
3. retinal atrophy
4. pregnancy
5. inability to obtain photographs or to perform FA
6. use of steroid systemically or topically in the last 6 months

Primary outcomes:
measure: the proportion of eyes with complete absorption of subretinal fluid (SRF)
timeFrame: 3 month
Secondary outcomes:
measure: Change of Best Corrected Visual Acuity (BCVA)
timeFrame: 1months,3 months and 6 months
measure: Change of fundus autofluorescence
timeFrame: 1months,3 months and 6 months
measure: Change in 10° retinal sensitivity
timeFrame: baseline,1months,3 months and 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chenjin Jin
role: PRINCIPAL_INVESTIGATOR
References: