Central Serous ChorioretinopathyLEVEONCT06346405
Central Serous Chorioretinopathy and Micropulse Laser Treatment
An observational study of Central Serous Chorioretinopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Subthreshold Micropulse Laser Treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2023to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli, IRCCS
Roma, R, 00168
Maria Cristina Savastano, MD, PhD, (+39)063015, mariacristinasavastano@policlinicogemelli.it
About this study
Official title: Central Serous Chorioretinopathy and Micropulse Laser Treatment: Evaluation of Morphological and Functional Recovery
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
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Subthreshold Micropulse Laser Treatment
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthreshold Micropulse Laser TreatmentOther
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%.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel density changes
Evaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment
Measured: 12 and 24 months
Secondary outcomes (9)
Choroidal thickness
Evaluation of changes in choroidal thickness before and after treatment.
Measured: 12 and 24 months
Choroidal thickness and vessel density
Correlation among changes in choroidal thickness and changes in vessel density of choriocapillary with best corrected visual acuity.
Measured: 12 and 24 months
Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern
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.
Measured: 12 and 24 months
Metamorphopsia
Evaluation of quantitative improvement of metamorphosia by M-CHARTS after treatment.
Measured: 12 and 24 months
Metamorphopsia and BCVA
Correlation between metamorphopsia and best corrected visual acuity (BCVA)
Measured: 12 and 24 months
Ellipsoid Zone Integrity
Evaluation of ellipsoid zone integrity by optical coherence tomography (OCT) B scan.
Measured: 12 and 24 months
Improvement in retinal function
To evaluate the potential improvement in retinal function with mean retinal sensitivity and microperimetry.
Measured: 12 and 24 months
Quality of life (QoL)
Evaluation of correlation among quality of life parameters assessed by visual function questionnaire (VFQ), stress and relapses and visual acuity.
Measured: 12 and 24 months
Ellipsoid zone and BCVA
To evaluate the association between ellipsoid zone integrity on optical coherence tomography (OCT) B scan and best corrected visual acuity (BCVA)
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start31 May 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savastano Maria Cristina, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346405
- Sponsor's protocol ID
- 10
- Acronym
- LEVEO
- Status last verified
- Sep 2025
- First submitted
- 5 Mar 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Serous Chorioretinopathy and Micropulse Laser Treatment: Evaluation of Morphological and Functional Recovery
- ClinicalTrials.gov ID
- NCT06346405
- Acronym / sponsor ID
- LEVEO / 10
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subthreshold Micropulse Laser TreatmentSubthreshold 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%. | Other | – |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Serous Chorioretinopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Cristina Savastano, MD, PhD ((+39)063015, mariacristinasavastano@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel density changes (time frame: 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.