Treatment Trial for Acute Central Serous Chorioretinopathy

Jin Chen-jin

Status: Completed

Conditions: Acute Central Serous Chorioretinopathy

Treatments: Device: 577-TL; Device: 577-MPL

Study type: Interventional

Funder types: Other

Identifiers

NCT02784665

577MPTAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

577-MPL

Experimental group

Description:

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.

Treatment:

Device: 577-MPL

577-TL

Active Comparator group

Description:

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.

Treatment:

Device: 577-TL