Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE

University Hospital, Bordeaux

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Central Serous Chorioretinopathy

Interventions

micropulse laserDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

central macular thickness

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

Time frame: Month 3

Secondary Outcomes

central retinal thickness

central retinal thickness (micrometers)

Time frame: 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

Time frame: Baseline, Month 3

eye sensitivity

eye sensitivity measured with microperimetry in decibels (dB)

Time frame: Baseline, Month 3

presence of sub-retinal fluid

presence of sub-retinal fluid on Spectral-Domain Optical Coherence Tomography (SD-OCT)

Time frame: Baseline, Month 3

presence of intraretinal cysts

presence of intraretinal cysts on SD-OCT

Time frame: Baseline, Month 3

presence of flat irregular pigment epithelium detachment

presence of flat irregular pigment epithelium detachment (FIPED) on SD-OCT

Time frame: Baseline, Month 3

Data from ClinicalTrials.gov

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