Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE

NCT ID: NCT05679180

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-11
• Study Completion Date: 2023-05-24

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)

Conditions

Central Serous Chorioretinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

micropulse laser

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CHUBX 2021/39

Identifier Type: -

Identifier Source: org_study_id