Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

Related Clinical Trial
Different Doses of vPDT in the Treatment of cCSC Eplerenone Versus PDT: Comparative Study by OCTA Pilot Study on Deep Learning in the Eye Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy OCT in Rare Chorioretinal Diseases Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO Selective RPE Laser Treatment (SRT) for Various Macular Diseases Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases Intravitreal Bevacizumab for the Treatment of Central Serous Chorioretinopathy Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC) Eye Patch Therapy for Central Serous Retinopathy (CSR) Multimodal Imaging in Central Serous Chorioretinopathy PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy Pseudo-PDT in Central Serous Chorioretinopathy Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC) Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC) Selective Retina Therapy With Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Retinopathy Effects of OCTA-guided PDT in Acute CSC Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy Treatment Trial for Acute Central Serous Chorioretinopathy The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole Selective Retina Therapy With ‘R:GEN’ in Patients With Central Serous Chorioretinopathy 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy Central Serous Chorioretinopathy: Etiology, Course and Prognosis A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy Treatment of Chronic Central Serous Chorioretinopathy Via Electromagnetic Stimulation and Platelet- Rich Plasma Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy Eplerenone for the Treatment of Central Serous Chorioretinopathy Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC) Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR) Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate Short-Term Oral Mifepristone for Central Serous Chorioretinopathy Methotrexate for Central Serous Chorioretinopathy Treatment Trial Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy Prospective Randomized Controlled Treatment Trial for Chronic Central Serous Chorioretinopathy The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy Eplerenone for Central Serous Chorioretinopathy High-dose Antioxidants for Central Serous Chorioretinopathy

Brief Title

Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

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 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 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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Change of Best Corrected Visual Acuity (BCVA)

Secondary Outcome

 the number of patients without any subretinal fluid (SRF)

Condition

Central Serous Choroidopathy

Intervention

577-MPL

Study Arms / Comparison Groups

 577-MPL
Description:  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.

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

88

Start Date

March 2016

Completion Date

September 2017

Primary Completion Date

September 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with CSC;

          2. age>=18 years old;

          3. Duration is less than 6 months;

          4. the presence of subretinal fluid(SRF) involving the macula and detected by use of
             optical coherence tomography (OCT), and CRT>=250um;

          5. active leakage located at ring 2 and ring 3 (ETDRS rings) on fluorescein angiography
             (FA).

        Exclusion Criteria:

          1. Patients with no case of CSC;

          2. Patients with other macular comorbidities including but not limited to diabetic
             retinopathy, macular degeneration;

          3. Patients with prior retinal treatment less than 3 months;

          4. Inability to obtain photographs or to perform FA
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02735213

Organization ID

Y-2016005


Responsible Party

Principal Investigator

Study Sponsor

The Eye Hospital of Wenzhou Medical University


Study Sponsor

, , 


Verification Date

July 2019