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Treatment Trial for Acute Central Serous Chorioretinopathy

Primary Purpose

Acute Central Serous Chorioretinopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
577-MPL
577-TL
Sponsored by
Jin Chen-jin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Central Serous Chorioretinopathy focused on measuring CSC, Micropulse Laser, Traditional Laser

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

577-MPL

577-TL

Arm 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.

577nm Traditional laser(577-TL) 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.

Outcomes

Primary Outcome Measures

the proportion of eyes with complete absorption of subretinal fluid (SRF)
The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)

Secondary Outcome Measures

Change of Best Corrected Visual Acuity (BCVA)
Change of fundus autofluorescence
Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment
Change in 10° retinal sensitivity

Full Information

First Posted
May 23, 2016
Last Updated
August 14, 2018
Sponsor
Jin Chen-jin
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1. Study Identification

Unique Protocol Identification Number
NCT02784665
Brief Title
Treatment Trial for Acute Central Serous Chorioretinopathy
Official Title
Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jin Chen-jin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger patients. It is characterized by serous detachment of the neurosensory retina with or without serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be treated with traditional laser photocoagulation, but it has the side effects of causing RPE atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment but it's more than most families can afford to pay because of the high cost, what's more, it is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium (RPE) atrophy and RPE rip. To date there is no international consensus on the optimal treatment of CSC Many retrospective studies suggest that micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute central serous chorioretinopathy compared with the traditional laser coagulation.
Detailed Description
The study is a prospective randomized controlled trial about 577nm micropulse laser versus traditional laser coagulation therapy on acute central serous chorioretinopathy. The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid 3 months after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Central Serous Chorioretinopathy
Keywords
CSC, Micropulse Laser, Traditional Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
577-MPL
Arm Type
Experimental
Arm 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.
Arm Title
577-TL
Arm Type
Active Comparator
Arm Description
577nm Traditional laser(577-TL) 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.
Intervention Type
Device
Intervention Name(s)
577-MPL
Intervention Description
All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the
Intervention Type
Device
Intervention Name(s)
577-TL
Intervention Description
All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-TL arm. 100 microns light spot size, 0.05 seconds duration, 80 ~ 200 milliwatts of power
Primary Outcome Measure Information:
Title
the proportion of eyes with complete absorption of subretinal fluid (SRF)
Description
The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Change of Best Corrected Visual Acuity (BCVA)
Time Frame
1months,3 months and 6 months
Title
Change of fundus autofluorescence
Description
Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment
Time Frame
1months,3 months and 6 months
Title
Change in 10° retinal sensitivity
Time Frame
baseline,1months,3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: onset for the first time, as an episode duration of less than 6 months patient was between 18 and 55 years of age the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT) active fluorescein leakage during fluorescein angiography (FA) best corrected visual acuity (BCVA) more than 0.1, and less than 1.0 Exclusion Criteria: previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV) retinal atrophy pregnancy inability to obtain photographs or to perform FA use of steroid systemically or topically in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenjin Jin
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Treatment Trial for Acute Central Serous Chorioretinopathy

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