Clinical Trial: Treatment Trial for Acute Central Serous Chorioretinopathy

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Jin Chen-jin

Current Primary Outcome: 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)


Original Primary Outcome: the proportion of eyes with complete absorption of subretinal fluid (SRF) [ Time Frame: 6 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)


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Change of Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 month ]
  • Change of fundus autofluorescence [ Time Frame: 6 month ]
    Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment
  • Change in 10° retinal sensitivity [ Time Frame: 6 month ]


Information By: Sun Yat-sen University

Dates:
Date Received: May 23, 2016
Date Started: April 2016
Date Completion: July 2018
Last Updated: April 19, 2017
Last Verified: April 2017