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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
Beijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 25, 2022
    Last Updated
    January 13, 2023
    Sponsor
    Beijing Hospital
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    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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