Central Serous Chorioretinopathy and Micropulse Laser Treatment (LEVEO)

Central Serous Chorioretinopathy and Micropulse Laser Treatment: Evaluation of Morphological and Functional Recovery

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

Study Overview

• Status: Recruiting
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Other: Subthreshold Micropulse Laser Treatment

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Maria Cristina Savastano, MD, PhD; Phone Number: (+39)063015; Email: mariacristinasavastano@policlinicogemelli.it

Study Locations

• Italy
  • R
    • Roma, R, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Agostino Gemelli, IRCCS
      • Contact: Maria Cristina Savastano, MD, PhD; Phone Number: (+39)063015; Email: mariacristinasavastano@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years old, with diagnosis of central serous chorioretinopathy since at least 6 months, undergone Acetazolamide and/or Eplerenone therapy with no improvement after 6 months.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness	Evaluation of changes in choroidal thickness before and after treatment.	12 and 24 months
Choroidal thickness and vessel density	Correlation among changes in choroidal thickness and changes in vessel density of choriocapillary with best corrected visual acuity.	12 and 24 months
Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern	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.	12 and 24 months
Metamorphopsia	Evaluation of quantitative improvement of metamorphosia by M-CHARTS after treatment.	12 and 24 months
Metamorphopsia and BCVA	Correlation between metamorphopsia and best corrected visual acuity (BCVA)	12 and 24 months
Ellipsoid Zone Integrity	Evaluation of ellipsoid zone integrity by optical coherence tomography (OCT) B scan.	12 and 24 months
Improvement in retinal function	To evaluate the potential improvement in retinal function with mean retinal sensitivity and microperimetry.	12 and 24 months
Quality of life (QoL)	Evaluation of correlation among quality of life parameters assessed by visual function questionnaire (VFQ), stress and relapses and visual acuity.	12 and 24 months
Ellipsoid zone and BCVA	To evaluate the association between ellipsoid zone integrity on optical coherence tomography (OCT) B scan and best corrected visual acuity (BCVA)	12 and 24 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No