Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
Primary Purpose
Central Serous Chorioretinopathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
100μm laser spot diameter micropulse laser
200μm laser spot diameter micropulse laser
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy
Eligibility Criteria
Inclusion Criteria: Patients age range 18-50 years Patients diagnosed with chronic Central serous chorioretinopathy Patients have signed informed consent Exclusion Criteria: A history of other fundus diseases or refractive media opacity Patients have underwent other treatment methods for chronic Central serous chorioretinopathy Diopter>-6D A history of system diseases such as hypertension or diabetes A history of using local or systemic corticosteroids
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
100μm laser spot diameter group
200μm laser spot diameter group
Arm Description
Outcomes
Primary Outcome Measures
Subretinal fluid regression ratio
Comparing the subretinal fluid regression ratio of two groups at 6 months follow-up
Central retinal thickness changes
Comparing the central retinal thickness changes of two groups at 6 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05687422
Brief Title
Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
Official Title
A Randomized Controlled Study of Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Central serous chorioretinopathy (CSC) is a common eye disease mainly involving the macular area, causing central visual acuity loss. Recently, subthreshold micropulse laser used in treating chronic CSC is proved to be safe and effective. However, some studies indicate that it's less effective than half dose photodynamic therapy (PDT). Certain physicians, including us, think that this may be related to micropulse laser parameters. Thus we need to explore better laser patterns to replace PDT in treating chronic CSC. The aim of this study is to compare the treatment effect of two different patterns of laser parameters (small and regular spot diameter) in treating chronic CSC. In this randomized, double blinded, controlled trial, by comparing the subretinal fluid regression ratio, central retinal thickness, macular microvisual field, macular vascular density, chroidal volume changes and visual acuity of two groups 6 months after micropulse laser treatment, we aim to evaluate the safety and efficacy of refined micropulse laser in treating chronic CSC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
100μm laser spot diameter group
Arm Type
Experimental
Arm Title
200μm laser spot diameter group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
100μm laser spot diameter micropulse laser
Intervention Description
100μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months
Intervention Type
Procedure
Intervention Name(s)
200μm laser spot diameter micropulse laser
Intervention Description
200μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months
Primary Outcome Measure Information:
Title
Subretinal fluid regression ratio
Description
Comparing the subretinal fluid regression ratio of two groups at 6 months follow-up
Time Frame
6 months
Title
Central retinal thickness changes
Description
Comparing the central retinal thickness changes of two groups at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients age range 18-50 years
Patients diagnosed with chronic Central serous chorioretinopathy
Patients have signed informed consent
Exclusion Criteria:
A history of other fundus diseases or refractive media opacity
Patients have underwent other treatment methods for chronic Central serous chorioretinopathy
Diopter>-6D
A history of system diseases such as hypertension or diabetes
A history of using local or systemic corticosteroids
12. IPD Sharing Statement
Learn more about this trial
Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
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