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Completed

NCT Number: NCT02735213

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The eye of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with CSC;
  • age>=18 years old;
  • Duration is less than 6 months;
  • the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT), and CRT>=250um;
  • active leakage located at ring 2 and ring 3 (ETDRS rings) on fluorescein angiography (FA).

Exclusion criteria

  • Patients with no case of CSC;
  • Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration;
  • Patients with prior retinal treatment less than 3 months;
  • Inability to obtain photographs or to perform FA

Treatment and study plan

577-MPL

Device

9 spots multispot micropulse mode(without spacing between the spots),160 um spot size, 0.2 second duration, 5% duty cycle(ON time 0.1ms + OFF time 1.9ms), and 250~400 milliWatts of power(50% threshold power),150~200 spots, the laser area is the corresponding leakage on mid-phase FA and around leakage.

TLT

Device

contimuous wave,100um spot size, 0.05 seconds duration, 55~60 milliwatts of power, 18~27 spots,the laser area is the corresponding leakage on mid-phase FA.

Primary outcomes

  1. Change of Best Corrected Visual Acuity (BCVA)

    Time frame: 12 week

    ETDRS BCVA

Secondary outcomes

  1. the number of patients without any subretinal fluid (SRF)

    Time frame: 3 week, 7 week, 12 week

    SRF

  2. Change of the central retinal thickness (CRT)

    Time frame: 3 week, 7 week, 12 week

    CRT

  3. laser scar in area lasered on

    Time frame: 12 week

    colour image and OCT infared image

  4. the number of patients need retreatment

    Time frame: 12 week

    PRN (pro re nata), only for SRF not completely absorbed and CRT >=250um

Sponsors and collaborators

Lead sponsor

The Eye Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2016
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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