Clinical trial NCT05679180: Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE
Official title: Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Central Serous Chorioretinopathy
Keywords: retina
photodynamic therapy
micropulse laser
central serous chorioretinopathy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: central macular thickness
timeFrame: Month 3
Secondary outcomes:
measure: central retinal thickness
timeFrame: Baseline, Month 3
measure: visual acuity
timeFrame: Baseline, Month 3
measure: eye sensitivity
timeFrame: Baseline, Month 3
measure: presence of sub-retinal fluid
timeFrame: Baseline, Month 3
measure: presence of intraretinal cysts
timeFrame: Baseline, Month 3
measure: presence of flat irregular pigment epithelium detachment
timeFrame: Baseline, Month 3
measure: presence of neovascularization
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
Study officials:
References: