Central Serous Chorioretinopathy and Micropulse Laser Treatment

Recruiting

• Conditions: Central Serous Chorioretinopathy

• Registration Number: NCT06346405
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Diagnosis of central serous chorioretinopathy (CSC) with no response to conservative therapy, consisted in Acetazolamide and Eplerenone after six months.
• Foveal serous retinal detachment for at least 6 months.
• Minimum age of 18 years old at the screening time
• Reading and comprehension skills of informed consent

Exclusion Criteria

• Previous retinal treatment for CSC, except for Acetazolamide and Eplerenone
• No diffuse retinal epitheliopathy
• Other concomitant ocular diseases, such as age related macular degeneration, diabetic retinopathy, choroidal neovascularization
• Not controlled glaucoma with eyedrops, or advanced glaucoma
• Myopia or hypermetropia greater than 6 diopters
• Opacities of dioptric media
• Low quality of optical coherence tomography (OCT) and OCT-Angiography scans
• Low quality images of Fluorescein angiography and indocyanine green angiography
• No written consensus signed.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vessel density changes	12 and 24 months	Evaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment

Secondary Outcome Measures

Name	Time	Method
Choroidal thickness	12 and 24 months	Evaluation of changes in choroidal thickness before and after treatment.
Ellipsoid Zone Integrity	12 and 24 months	Evaluation of ellipsoid zone integrity by optical coherence tomography (OCT) B scan.
Quality of life (QoL)	12 and 24 months	Evaluation of correlation among quality of life parameters assessed by visual function questionnaire (VFQ), stress and relapses and visual acuity.
Metamorphopsia	12 and 24 months	Evaluation of quantitative improvement of metamorphosia by M-CHARTS after treatment.
Choroidal thickness and vessel density	12 and 24 months	Correlation among changes in choroidal thickness and changes in vessel density of choriocapillary with best corrected visual acuity.
Improvement in retinal function	12 and 24 months	To evaluate the potential improvement in retinal function with mean retinal sensitivity and microperimetry.
Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern	12 and 24 months	To qualitatively evaluate the vascular patterns using optical coherence tomography (OCT) - angiography and to verify if a particular one is associated with a greater response to subthreshold micropulse laser treatment.
Ellipsoid zone and BCVA	12 and 24 months	To evaluate the association between ellipsoid zone integrity on optical coherence tomography (OCT) B scan and best corrected visual acuity (BCVA)
Metamorphopsia and BCVA	12 and 24 months	Correlation between metamorphopsia and best corrected visual acuity (BCVA)

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli, IRCCS; 🇮🇹 Roma, R, Italy