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Trial record 33 of 141 for:    MPL

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

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ClinicalTrials.gov Identifier: NCT02735213
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoling Liu, The Eye Hospital of Wenzhou Medical University

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

Condition or disease Intervention/treatment Phase
Central Serous Choroidopathy Device: 577-MPL Device: TLT Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
Study Start Date : March 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 577-MPL
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.
Device: 577-MPL
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.

Active Comparator: TLT
Traditional laser will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Traditional 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.
Device: TLT
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 Outcome Measures :
  1. Change of Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 week ]
    ETDRS BCVA


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735213


Locations
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China, Zhejiang
The eye of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
The Eye Hospital of Wenzhou Medical University

Publications:
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Responsible Party: Xiaoling Liu, professor, The Eye Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02735213     History of Changes
Other Study ID Numbers: Y-2016005
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

Keywords provided by Xiaoling Liu, The Eye Hospital of Wenzhou Medical University:
Central Serous Choroidopathy
Micropulse Laser Treatment
Traditional laser Treatment
optical coherence tomography

Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Choroid Diseases
Retinal Diseases
Eye Diseases
Uveal Diseases