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

MICROPULSE study aims to evaluate the efficacy of navigated microsecond laser (nMSL) for chronic central serous chorioretinopathy (CSCR).

Study Overview

• Status: Withdrawn
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Device: micropulse laser

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)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micropulse laser; 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.	Device: micropulse laser; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central macular thickness	central macular thickness measured in microns and determined on spectral-domain OCT	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central retinal thickness	central retinal thickness (micrometers)	Baseline, Month 3
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	Baseline, Month 3
eye sensitivity	eye sensitivity measured with microperimetry in decibels (dB)	Baseline, Month 3
presence of sub-retinal fluid	presence of sub-retinal fluid on Spectral-Domain Optical Coherence Tomography (SD-OCT)	Baseline, Month 3
presence of intraretinal cysts	presence of intraretinal cysts on SD-OCT	Baseline, Month 3
presence of flat irregular pigment epithelium detachment	presence of flat irregular pigment epithelium detachment (FIPED) on SD-OCT	Baseline, Month 3
presence of neovascularization	presence of type 1 neovascularization on OCT-angiography	Baseline, Month 3

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Actual): May 24, 2023
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: micropulse laser; photodynamic therapy; central serous chorioretinopathy; retina
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: CHUBX 2021/39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No