Green Subthreshold Laser Therapy for Chronic Central Serous Chorioretinopathy.

June 12, 2025 updated by: Gilda Cennamo, Federico II University

Efficacy of Green Subthreshold Laser Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Chronic Central Serous Chorioretinopathy (CSCR) is a vision-threatening retinal disorder characterized by persistent subretinal fluid due to choroidal vascular hyperpermeability and retinal pigment epithelium (RPE) dysfunction. This study evaluates the efficacy and safety of green subthreshold laser therapy using Norlase µSec Technology as a novel, tissue-sparing approach for treating chronic CSCR. By targeting RPE repair without inducing visible retinal damage, this technique aims to resolve subretinal fluid, restore retinal architecture, and improve visual function. This is the first study to report clinical outcomes with this specific laser platform in chronic CSCR management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • University of Naples Federico II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients diagnosed with chronic Central Serous Chorioretinopathy (CSCR), defined by the presence of subretinal fluid (SRF) persisting for more than 4 months, as confirmed by optical coherence tomography (OCT)

Description

Inclusion Criteria:

Subretinal fluid for more than three months, confirmed by multimodal imaging, diagnosis of chronic CSC in at least one eye.

Exclusion Criteria:

any evidence of choroidal neovascularization on multimodal imaging, as well as a history of previous photodynamic therapy (PDT) or focal laser treatment for CSC, prior diagnosis of ocular hypertension, glaucoma, and optic nerve disorders, presence of active retinal conditions such as vitreomacular traction, epiretinal membrane, diabetic retinopathy, or retinal vein occlusion, lens opacities that could interfere with retinal imaging or compromise visual acuity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in central foveal thickness
Time Frame: 3 months
to evaluate changen in Central foveal tickness (CFT), assessed on OCT images by manually placing calipers between the internal limiting membrane and the outer boundary of the retinal pigment epithelium, before and after treatment.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

June 12, 2025

First Posted (Actual)

June 13, 2025

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05809855 Federico II

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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