search
Back to results

Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE (MICROPULSE)

Primary Purpose

Central Serous Chorioretinopathy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
micropulse laser
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring retina, photodynamic therapy, micropulse laser, central serous chorioretinopathy

Eligibility Criteria

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

Inclusion Criteria: 18 years and older vision complaints for more than 6 weeks subretinal fluid confirmed on OCT diagnosis of CSCR confirmed by fluorescein and indocyanine green angiography Signed informed consent Affiliated or beneficiary of health insurance Exclusion Criteria: History of treatment of CSC with other modalities (PDT, eplerenone) in the past 3 months Other macular conditions : Age-related Macular Degeneration (AMD), polypoidal vasculopathy, choroidal neovascularization Cataract or opacities interfering with acquisition or treatment Myopia> 6 diopter Visual acuity<20/200 Treatment with steroids (per-os, inhaled or cutaneous) in the past 3 months Intra-vitreal injections of anti-VEGF (Vascular Endothelial Growth Factor) or steroids in the past 3 months History of allergy to fluorescein or indocyanine Inability to agree to participate to the study Pregnant or breastfeeding woman Patient under legal protection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    micropulse laser

    Arm Description

    treatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used.

    Outcomes

    Primary Outcome Measures

    central macular thickness
    central macular thickness measured in microns and determined on spectral-domain OCT

    Secondary Outcome Measures

    central retinal thickness
    central retinal thickness (micrometers)
    visual acuity
    visual acuity via ETDRS (Early Treatment of Diabetic Retinopathy Study) scale. The EDTRS scale is expressed in number of letters read. The scale is logarithmic, i.e. the progression between the 14 lines is geometric (by a factor equal to the cube root of 2). A loss of 3 lines of visual acuity thus corresponds to a doubling of the visual angle.This allows to determine the necessary corrections (sphere, cylinder, axis
    eye sensitivity
    eye sensitivity measured with microperimetry in decibels (dB)
    presence of sub-retinal fluid
    presence of sub-retinal fluid on Spectral-Domain Optical Coherence Tomography (SD-OCT)
    presence of intraretinal cysts
    presence of intraretinal cysts on SD-OCT
    presence of flat irregular pigment epithelium detachment
    presence of flat irregular pigment epithelium detachment (FIPED) on SD-OCT
    presence of neovascularization
    presence of type 1 neovascularization on OCT-angiography

    Full Information

    First Posted
    December 28, 2022
    Last Updated
    May 25, 2023
    Sponsor
    University Hospital, Bordeaux
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05679180
    Brief Title
    Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE
    Acronym
    MICROPULSE
    Official Title
    Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study withdrawn by clinical team
    Study Start Date
    May 11, 2023 (Actual)
    Primary Completion Date
    May 24, 2023 (Actual)
    Study Completion Date
    May 24, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Bordeaux

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    MICROPULSE study aims to evaluate the efficacy of navigated microsecond laser (nMSL) for chronic central serous chorioretinopathy (CSCR).
    Detailed Description
    Chronic central serous chorioretinopathy (CSCR) is characterized by persistent subretinal fluid (SRF) and extensive outer retinal damage on optical coherence tomography (OCT). In the last years several treatment modalities for chronic CSCR have been investigated. These treatments have included pharmacologic therapy, photodynamic therapy (PDT) and microsecond laser. PDT is the main treatment for CSCR, especially for chronic CSCR. But the efficacy of PDT is variable and could be associated with various complications such as retinal pigment epithelium (RPE) atrophy. Furthermore other limitations of PDT are unavailability and high cost. Recently some studies have suggested an efficacy of micropulse laser in chronic CSCR, with stabilization of visual acuity, improvement in retinal sensitivity and without any complications. The present study aims to evaluate the efficacy of a treatment by guided micropulse laser in the management of chronic CSCR. The efficacity will be evaluated 6 weeks and 3 months after the treatment on anatomical outcomes (central macular thickness in microns)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Serous Chorioretinopathy
    Keywords
    retina, photodynamic therapy, micropulse laser, central serous chorioretinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    micropulse laser
    Arm Type
    Experimental
    Arm Description
    treatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used.
    Intervention Type
    Device
    Intervention Name(s)
    micropulse laser
    Intervention Description
    treatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used.
    Primary Outcome Measure Information:
    Title
    central macular thickness
    Description
    central macular thickness measured in microns and determined on spectral-domain OCT
    Time Frame
    Month 3
    Secondary Outcome Measure Information:
    Title
    central retinal thickness
    Description
    central retinal thickness (micrometers)
    Time Frame
    Baseline, Month 3
    Title
    visual acuity
    Description
    visual acuity via ETDRS (Early Treatment of Diabetic Retinopathy Study) scale. The EDTRS scale is expressed in number of letters read. The scale is logarithmic, i.e. the progression between the 14 lines is geometric (by a factor equal to the cube root of 2). A loss of 3 lines of visual acuity thus corresponds to a doubling of the visual angle.This allows to determine the necessary corrections (sphere, cylinder, axis
    Time Frame
    Baseline, Month 3
    Title
    eye sensitivity
    Description
    eye sensitivity measured with microperimetry in decibels (dB)
    Time Frame
    Baseline, Month 3
    Title
    presence of sub-retinal fluid
    Description
    presence of sub-retinal fluid on Spectral-Domain Optical Coherence Tomography (SD-OCT)
    Time Frame
    Baseline, Month 3
    Title
    presence of intraretinal cysts
    Description
    presence of intraretinal cysts on SD-OCT
    Time Frame
    Baseline, Month 3
    Title
    presence of flat irregular pigment epithelium detachment
    Description
    presence of flat irregular pigment epithelium detachment (FIPED) on SD-OCT
    Time Frame
    Baseline, Month 3
    Title
    presence of neovascularization
    Description
    presence of type 1 neovascularization on OCT-angiography
    Time Frame
    Baseline, Month 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years and older vision complaints for more than 6 weeks subretinal fluid confirmed on OCT diagnosis of CSCR confirmed by fluorescein and indocyanine green angiography Signed informed consent Affiliated or beneficiary of health insurance Exclusion Criteria: History of treatment of CSC with other modalities (PDT, eplerenone) in the past 3 months Other macular conditions : Age-related Macular Degeneration (AMD), polypoidal vasculopathy, choroidal neovascularization Cataract or opacities interfering with acquisition or treatment Myopia> 6 diopter Visual acuity<20/200 Treatment with steroids (per-os, inhaled or cutaneous) in the past 3 months Intra-vitreal injections of anti-VEGF (Vascular Endothelial Growth Factor) or steroids in the past 3 months History of allergy to fluorescein or indocyanine Inability to agree to participate to the study Pregnant or breastfeeding woman Patient under legal protection

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE

    We'll reach out to this number within 24 hrs