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

Primary Purpose

Central Serous Choroidopathy

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
577-MPL
TLT
Sponsored by
The Eye Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Choroidopathy focused on measuring Central Serous Choroidopathy, Micropulse Laser Treatment, Traditional laser Treatment, optical coherence tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The eye of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

577-MPL

TLT

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change of Best Corrected Visual Acuity (BCVA)
ETDRS BCVA

Secondary Outcome Measures

the number of patients without any subretinal fluid (SRF)
SRF
Change of the central retinal thickness (CRT)
CRT
laser scar in area lasered on
colour image and OCT infared image
the number of patients need retreatment
PRN (pro re nata), only for SRF not completely absorbed and CRT >=250um

Full Information

First Posted
March 16, 2016
Last Updated
July 17, 2019
Sponsor
The Eye Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02735213
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Eye Hospital of Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Choroidopathy
Keywords
Central Serous Choroidopathy, Micropulse Laser Treatment, Traditional laser Treatment, optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
577-MPL
Arm Type
Experimental
Arm 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.
Arm Title
TLT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
577-MPL
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TLT
Intervention Description
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 Measure Information:
Title
Change of Best Corrected Visual Acuity (BCVA)
Description
ETDRS BCVA
Time Frame
12 week
Secondary Outcome Measure Information:
Title
the number of patients without any subretinal fluid (SRF)
Description
SRF
Time Frame
3 week, 7 week, 12 week
Title
Change of the central retinal thickness (CRT)
Description
CRT
Time Frame
3 week, 7 week, 12 week
Title
laser scar in area lasered on
Description
colour image and OCT infared image
Time Frame
12 week
Title
the number of patients need retreatment
Description
PRN (pro re nata), only for SRF not completely absorbed and CRT >=250um
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The eye of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26691378
Citation
Salehi M, Wenick AS, Law HA, Evans JR, Gehlbach P. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2015 Dec 22;2015(12):CD011841. doi: 10.1002/14651858.CD011841.pub2.
Results Reference
background
PubMed Identifier
26619293
Citation
Iacono P, Battaglia Parodi M, Falcomata B, Bandello F. Central Serous Chorioretinopathy Treatments: A Mini Review. Ophthalmic Res. 2015;55(2):76-83. doi: 10.1159/000441502. Epub 2015 Dec 1.
Results Reference
background
PubMed Identifier
26026923
Citation
Daruich A, Matet A, Dirani A, Bousquet E, Zhao M, Farman N, Jaisser F, Behar-Cohen F. Central serous chorioretinopathy: Recent findings and new physiopathology hypothesis. Prog Retin Eye Res. 2015 Sep;48:82-118. doi: 10.1016/j.preteyeres.2015.05.003. Epub 2015 May 27.
Results Reference
background
PubMed Identifier
11884873
Citation
Loo RH, Scott IU, Flynn HW Jr, Gass JD, Murray TG, Lewis ML, Rosenfeld PJ, Smiddy WE. Factors associated with reduced visual acuity during long-term follow-up of patients with idiopathic central serous chorioretinopathy. Retina. 2002 Feb;22(1):19-24. doi: 10.1097/00006982-200202000-00004.
Results Reference
background
PubMed Identifier
3061449
Citation
Ficker L, Vafidis G, While A, Leaver P. Long-term follow-up of a prospective trial of argon laser photocoagulation in the treatment of central serous retinopathy. Br J Ophthalmol. 1988 Nov;72(11):829-34. doi: 10.1136/bjo.72.11.829.
Results Reference
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Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

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