Clinical Trial: Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

Brief Summary: The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy.

Detailed Summary:

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 proportion of eyes with absorption of subretinal fluid (SRF) and re-treatment in 12 week.


Sponsor: The Eye Hospital of Wenzhou Medical University

Current Primary Outcome: the number of eyes without any subretinal fluid (SRF) [ Time Frame: 12 week ]

SRF


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of the central retinal thickness (CRT) [ Time Frame: 3 week, 7 week, 12 week ]
    CRT
  • Change of Best Corrected Visual Acuity (BCVA) [ Time Frame: 3 week, 7 week, 12 week ]
    ETDRS BCVA
  • laser scar in area lasered on [ Time Frame: 7 week, 12 week ]
    colour image and OCT
  • Change of leakages on fundus fluorescence angiography [ Time Frame: 12 week ]
    PRN (pro re nata), only for SRF not completely absorbed


Original Secondary Outcome: Same as current

Information By: The Eye Hospital of Wenzhou Medical University

Dates:
Date Received: March 16, 2016
Date Started: March 2016
Date Completion: September 2017
Last Updated: May 15, 2017
Last Verified: May 2017