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Treatment Trial for Acute Central Serous Chorioretinopathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02784665
Enrollment
110
Registered
2016-05-27
Start date
2016-04-30
Completion date
2018-03-31
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Central Serous Chorioretinopathy

Keywords

CSC, Micropulse Laser, Traditional Laser

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.

Interventions

DEVICE577-MPL

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

DEVICE577-TL

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

Sponsors

Jin Chen-jin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the proportion of eyes with complete absorption of subretinal fluid (SRF)3 monthThe 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

MeasureTime frameDescription
Change of Best Corrected Visual Acuity (BCVA)1months,3 months and 6 months
Change of fundus autofluorescence1months,3 months and 6 monthsFundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment
Change in 10° retinal sensitivitybaseline,1months,3 months and 6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026