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NCT Number: NCT06346405

Central Serous Chorioretinopathy and Micropulse Laser Treatment

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

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Key information

Conditions

Central Serous Chorioretinopathy Eye Diseases Retinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Agostino Gemelli, IRCCS

Roma, R, 00168, Italy

Location status: Recruiting

Location contact

Maria Cristina Savastano, MD, PhD

CONTACT

[email protected]

(+39)063015

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subthreshold Micropulse Laser Treatment

Other

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 outcomes

  1. 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

  1. Choroidal thickness

    Time frame: 12 and 24 months

    Evaluation of changes in choroidal thickness before and after treatment.

  2. Choroidal thickness and vessel density

    Time frame: 12 and 24 months

    Correlation among changes in choroidal thickness and changes in vessel density of choriocapillary with best corrected visual acuity.

  3. Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern

    Time frame: 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.

  4. Metamorphopsia

    Time frame: 12 and 24 months

    Evaluation of quantitative improvement of metamorphosia by M-CHARTS after treatment.

  5. Metamorphopsia and BCVA

    Time frame: 12 and 24 months

    Correlation between metamorphopsia and best corrected visual acuity (BCVA)

  6. Ellipsoid Zone Integrity

    Time frame: 12 and 24 months

    Evaluation of ellipsoid zone integrity by optical coherence tomography (OCT) B scan.

  7. Improvement in retinal function

    Time frame: 12 and 24 months

    To evaluate the potential improvement in retinal function with mean retinal sensitivity and microperimetry.

  8. Quality of life (QoL)

    Time frame: 12 and 24 months

    Evaluation of correlation among quality of life parameters assessed by visual function questionnaire (VFQ), stress and relapses and visual acuity.

  9. Ellipsoid zone and BCVA

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Cristina Savastano, MD, PhD

CONTACT

[email protected]

(+39)063015

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: LEVEO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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