Treatment Trial for Acute Central Serous Chorioretinopathy

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Brief Title

Treatment Trial for Acute Central Serous Chorioretinopathy

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 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.
    


Study Type

Interventional


Primary Outcome

the proportion of eyes with complete absorption of subretinal fluid (SRF)

Secondary Outcome

 Change of Best Corrected Visual Acuity (BCVA)

Condition

Acute Central Serous Chorioretinopathy

Intervention

577-MPL

Study Arms / Comparison Groups

 577-MPL
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

110

Start Date

April 2016

Completion Date

March 2018

Primary Completion Date

March 2018

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Chenjin Jin, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02784665

Organization ID

577MPTAC


Responsible Party

Sponsor-Investigator

Study Sponsor

Jin Chen-jin


Study Sponsor

Chenjin Jin, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University


Verification Date

August 2018