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Recruiting NCT06346405

Central Serous Chorioretinopathy and Micropulse Laser Treatment

— Observational Central Serous Chorioretinopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Subthreshold Micropulse Laser Treatment.
Who it may be relevant to
Registry conditions: Central Serous Chorioretinopathy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Other Subthreshold Micropulse Laser Treatment
    Subthreshold micropulse laser treatment consists in 33 spots of 100 microns, distance among each spot of 2.50 microns, duration of 200 sec, power of 250 milliwatt (mW) duty cycle 5%.

Primary outcome measures

  • Vessel density changes [Time frame: 12 and 24 months]
Secondary outcome measures (9)
  • Choroidal thickness [Time frame: 12 and 24 months]
  • Choroidal thickness and vessel density [Time frame: 12 and 24 months]
  • Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern [Time frame: 12 and 24 months]
  • Metamorphopsia [Time frame: 12 and 24 months]
  • Metamorphopsia and BCVA [Time frame: 12 and 24 months]
  • Ellipsoid Zone Integrity [Time frame: 12 and 24 months]
  • Improvement in retinal function [Time frame: 12 and 24 months]
  • Quality of life (QoL) [Time frame: 12 and 24 months]
  • Ellipsoid zone and BCVA [Time frame: 12 and 24 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • Fondazione Policlinico Agostino Gemelli, IRCCS — Roma

Identifiers

NCT: NCT06346405 · 10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗