Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE

Central Serous Chorioretinopathy Clinical Trial

— MICROPULSE  

Official title:

Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05679180
• Other study ID #: CHUBX 2021/39
• Status: Withdrawn
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central macular thickness	central macular thickness measured in microns and determined on spectral-domain OCT	Month 3
Secondary	central retinal thickness	central retinal thickness (micrometers)	Baseline, Month 3
Secondary	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
Secondary	eye sensitivity	eye sensitivity measured with microperimetry in decibels (dB)	Baseline, Month 3
Secondary	presence of sub-retinal fluid	presence of sub-retinal fluid on Spectral-Domain Optical Coherence Tomography (SD-OCT)	Baseline, Month 3
Secondary	presence of intraretinal cysts	presence of intraretinal cysts on SD-OCT	Baseline, Month 3
Secondary	presence of flat irregular pigment epithelium detachment	presence of flat irregular pigment epithelium detachment (FIPED) on SD-OCT	Baseline, Month 3
Secondary	presence of neovascularization	presence of type 1 neovascularization on OCT-angiography	Baseline, Month 3