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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country36 target enrollmentMay 31, 2023

ConditionsCentral Serous Chorioretinopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Central Serous Chorioretinopathy
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment: 36
Locations: 1
Primary Endpoint: Vessel density changes
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 31, 2023

End Date

May 31, 2027

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Responsible Party

Principal Investigator

Savastano Maria Cristina

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Vessel density changes

Time Frame: 12 and 24 months

Evaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment

Secondary Outcomes

Choroidal thickness(12 and 24 months)
Quality of life (QoL)(12 and 24 months)
Metamorphopsia(12 and 24 months)
Choroidal thickness and vessel density(12 and 24 months)
Improvement in retinal function(12 and 24 months)
Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern(12 and 24 months)
Ellipsoid zone and BCVA(12 and 24 months)
Metamorphopsia and BCVA(12 and 24 months)
Ellipsoid Zone Integrity(12 and 24 months)