Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
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|ClinicalTrials.gov Identifier: NCT02735213|
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Central Serous Choroidopathy||Device: 577-MPL Device: TLT||Phase 2 Phase 3|
Central serous chorioretinopathy (CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity. Some studies have shown that traditional laser treatment (TLT) is effective on CSC, although accompanied with side-effects, such as scar. Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between TLT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus traditional laser treatment in central serous chorioretinopathy. It is a noninferiority study. The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity.This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment. The primary outcome measures is the change of BCVA in 12 week.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
577nm subthreshold micropulse laser(577-MPL) will be performed on the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein. Multiple laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um.
9 spots multispot micropulse mode(without spacing between the spots),160 um spot size, 0.2 second duration, 5% duty cycle(ON time 0.1ms + OFF time 1.9ms), and 250~400 milliWatts of power(50% threshold power),150~200 spots, the laser area is the corresponding leakage on mid-phase FA and around leakage.
Active Comparator: TLT
Traditional laser 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. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um.
contimuous wave,100um spot size, 0.05 seconds duration, 55~60 milliwatts of power, 18~27 spots,the laser area is the corresponding leakage on mid-phase FA.
- Change of Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 week ]ETDRS BCVA
- the number of patients without any subretinal fluid (SRF) [ Time Frame: 3 week, 7 week, 12 week ]SRF
- Change of the central retinal thickness (CRT) [ Time Frame: 3 week, 7 week, 12 week ]CRT
- laser scar in area lasered on [ Time Frame: 12 week ]colour image and OCT infared image
- the number of patients need retreatment [ Time Frame: 12 week ]PRN (pro re nata), only for SRF not completely absorbed and CRT >=250um
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735213
|The eye of Wenzhou Medical University|
|Wenzhou, Zhejiang, China, 325000|