Central Serous Chorioretinopathy and Micropulse Laser Treatment
LEVEO
1 other identifier
observational
36
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2023
CompletedFirst Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
September 23, 2025
September 1, 2025
4 years
March 5, 2024
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Vessel density changes
Evaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment
12 and 24 months
Secondary Outcomes (9)
Choroidal thickness
12 and 24 months
Choroidal thickness and vessel density
12 and 24 months
Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern
12 and 24 months
Metamorphopsia
12 and 24 months
Metamorphopsia and BCVA
12 and 24 months
- +4 more secondary outcomes
Interventions
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%.
Eligibility Criteria
Patients older than 18 years old, with diagnosis of central serous chorioretinopathy since at least 6 months, undergone Acetazolamide and/or Eplerenone therapy with no improvement after 6 months.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Agostino Gemelli, IRCCS
Roma, R, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2024
First Posted
April 4, 2024
Study Start
May 31, 2023
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
September 23, 2025
Record last verified: 2025-09