Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE

NCT05679180 | Withdrawn

• 1 other identifier: CHUBX 2021/39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Central Serous Chorioretinopathy

Keywords

retina; photodynamic therapy; micropulse laser; central serous chorioretinopathy

Outcome Measures

Primary Outcomes (1)

• central macular thickness

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

  Month 3

Secondary Outcomes (7)

• central retinal thickness

  Baseline, Month 3

• visual acuity

  Baseline, Month 3

• eye sensitivity

  Baseline, Month 3

• presence of sub-retinal fluid

  Baseline, Month 3

• presence of intraretinal cysts

  Baseline, Month 3

Study Arms (1)

micropulse laser

EXPERIMENTAL

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

Interventions

micropulse laser 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.

micropulse laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 10, 2023
• Study Start: May 11, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share