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Central Serous Chorioretinopathy and Micropulse Laser Treatment

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06346405
Acronym
LEVEO
Enrollment
36
Registered
2024-04-04
Start date
2023-05-31
Completion date
2027-05-31
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Serous Chorioretinopathy

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

Interventions

OTHERSubthreshold 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%.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Vessel density changes12 and 24 monthsEvaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment

Secondary

MeasureTime frameDescription
Choroidal thickness12 and 24 monthsEvaluation of changes in choroidal thickness before and after treatment.
Choroidal thickness and vessel density12 and 24 monthsCorrelation among changes in choroidal thickness and changes in vessel density of choriocapillary with best corrected visual acuity.
Metamorphopsia12 and 24 monthsEvaluation of quantitative improvement of metamorphosia by M-CHARTS after treatment.
Metamorphopsia and BCVA12 and 24 monthsCorrelation between metamorphopsia and best corrected visual acuity (BCVA)
Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern12 and 24 monthsTo 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.
Improvement in retinal function12 and 24 monthsTo evaluate the potential improvement in retinal function with mean retinal sensitivity and microperimetry.
Quality of life (QoL)12 and 24 monthsEvaluation of correlation among quality of life parameters assessed by visual function questionnaire (VFQ), stress and relapses and visual acuity.
Ellipsoid zone and BCVA12 and 24 monthsTo evaluate the association between ellipsoid zone integrity on optical coherence tomography (OCT) B scan and best corrected visual acuity (BCVA)
Ellipsoid Zone Integrity12 and 24 monthsEvaluation of ellipsoid zone integrity by optical coherence tomography (OCT) B scan.

Countries

Italy

Contacts

Primary ContactMaria Cristina Savastano, MD, PhD
mariacristinasavastano@policlinicogemelli.it(+39)063015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026