Treatment Trial for Acute Central Serous Chorioretinopathy
|ClinicalTrials.gov Identifier: NCT02784665|
Recruitment Status : Enrolling by invitation
First Posted : May 27, 2016
Last Update Posted : April 21, 2017
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.
|Condition or disease||Intervention/treatment|
|Acute Central Serous Chorioretinopathy||Device: 577-MPL Device: 577-TL|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||July 2018|
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.
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
Active Comparator: 577-TL
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.
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
- 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)
- Change of Best Corrected Visual Acuity (BCVA) [ Time Frame: 1months,3 months and 6 months ]
- Change of fundus autofluorescence [ Time Frame: 1months,3 months and 6 months ]Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment
- Change in 10° retinal sensitivity [ Time Frame: baseline,1months,3 months and 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784665
|Zhongshan Ophthalmic Center, Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Chenjin Jin||Zhongshan Ophthalmic Center, Sun Yet-sen University|