577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy

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Brief Title

577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy

Official Title

Prospective Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy

Brief Summary

      The purpose of this study is to determine whether micropulse laser (MPL) is different to
      half-dose photodynamic therapy on acute central serous chorioretinopathy.
    

Detailed Description

      Central serous chorioretinopathy(CSC) is characterized by serous detachment of neurosensory
      retina which can cause lose in visual acuity.Some studies have shown that Half-dose
      photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as
      choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant
      price.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 PDT and MPL.

      The study is the first prospective randomized controlled trial about 577nm micropulse laser
      versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null
      hypothesis of the study is that there is difference between MPL and half-dose photodynamic
      therapy on acute central serous chorioretinopathy at first month after treatment.The primary
      outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1
      month 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

68

Start Date

September 2016

Completion Date

December 2019

Primary Completion Date

December 2019

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

NCT02587767

Organization ID

577MPLACS(Marshall Study)


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Chenjin Jin, Study Director, Zhongshan Ophthalmic Center, Sun Yat-sen University


Verification Date

April 2022