the Presence of Subretinal Fluid (SRF)NCT07020793
Green Subthreshold Laser Therapy for Chronic Central Serous Chorioretinopathy.
An observational study of the Presence of Subretinal Fluid (SRF), run by Federico II University at 1 site in Italy.
Trial summary
Chronic Central Serous Chorioretinopathy (CSCR) is a vision-threatening retinal disorder characterized by persistent subretinal fluid due to choroidal vascular hyperpermeability and retinal pigment epithelium (RPE) dysfunction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- the Presence of Subretinal Fluid (SRF)
- What is being tested?
- green subthreshold laser therapy
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes adult patients diagnosed with chronic Central Serous Chorioretinopathy (CSCR), defined by the presence of subretinal fluid (SRF) persisting for more than 4 months, as confirmed by optical coherence tomography (OCT)
Who may be able to join
- Subretinal fluid for more than three months, confirmed by multimodal imaging, diagnosis of chronic CSC in at least one eye.
Who cannot join
- any evidence of choroidal neovascularization on multimodal imaging, as well as a history of previous photodynamic therapy (PDT) or focal laser treatment for CSC, prior diagnosis of ocular hypertension, glaucoma, and optic nerve disorders, presence of active retinal conditions such as vitreomacular traction, epiretinal membrane, diabetic retinopathy, or retinal vein occlusion, lens opacities that could interfere with retinal imaging or compromise visual acuity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Green Subthreshold Laser Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
Chronic Central Serous Chorioretinopathy (CSCR) is a vision-threatening retinal disorder characterized by persistent subretinal fluid due to choroidal vascular hyperpermeability and retinal pigment epithelium (RPE) dysfunction. This study evaluates the efficacy and safety of green subthreshold laser therapy using Norlase µSec Technology as a novel, tissue-sparing approach for treating chronic CSCR. By targeting RPE repair without inducing visible retinal damage, this technique aims to resolve subretinal fluid, restore retinal architecture, and improve visual function. This is the first study to report clinical outcomes with this specific laser platform in chronic CSCR management.
- Conditions
- the Presence of Subretinal Fluid (SRF)
- Being tested
- green subthreshold laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green subthreshold laser therapyProcedure or surgery
The intervention consists of green subthreshold laser therapy delivered using the Norlase µSec™ Technology, a novel microsecond-pulsed laser platform specifically designed for retinal treatments.
What is being measured
The primary outcome is the main question the study is designed to answer.
change in central foveal thickness
to evaluate changen in Central foveal tickness (CFT), assessed on OCT images by manually placing calipers between the internal limiting membrane and the outer boundary of the retinal pigment epithelium, before and after treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for the Presence of Subretinal Fluid (SRF)Studies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020793
- Sponsor's protocol ID
- 05809855 Federico II
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cennamo G, Rinaldi M, Passaro ML, Senese I, D'Aponte A, Costagliola C. Green subthreshold laser for chronic central serous chorioretinopathy: A new therapeutic approach. Photodiagnosis Photodyn Ther. 2026 Jul 29;61:105592. doi: 10.1016/j.pdpdt.2026.105592. Online ahead of print.
PubMed 42526611
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Green Subthreshold Laser Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT07020793
- Acronym / sponsor ID
- 05809855 Federico II
- Conditions
- the Presence of Subretinal Fluid (SRF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 13 Jun 2025 (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.
Chronic Central Serous Chorioretinopathy (CSCR) is a vision-threatening retinal disorder characterized by persistent subretinal fluid due to choroidal vascular hyperpermeability and retinal pigment epithelium (RPE) dysfunction. This study evaluates the efficacy and safety of green subthreshold laser therapy using Norlase µSec Technology as a novel, tissue-sparing approach for treating chronic CSCR. By targeting RPE repair without inducing visible retinal damage, this technique aims to resolve subretinal fluid, restore retinal architecture, and improve visual function. This is the first study to report clinical outcomes with this specific laser platform in chronic CSCR management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes adult patients diagnosed with chronic Central Serous Chorioretinopathy (CSCR), defined by the presence of subretinal fluid (SRF) persisting for more than 4 months, as confirmed by optical coherence tomography (OCT)
Key inclusion criteria (1 listed)
- Subretinal fluid for more than three months, confirmed by multimodal imaging, diagnosis of chronic CSC in at least one eye.
Key exclusion criteria (1 listed)
- any evidence of choroidal neovascularization on multimodal imaging, as well as a history of previous photodynamic therapy (PDT) or focal laser treatment for CSC, prior diagnosis of ocular hypertension, glaucoma, and optic nerve disorders, presence of active retinal conditions such as vitreomacular traction, epiretinal membrane, diabetic retinopathy, or retinal vein occlusion, lens opacities that could interfere with retinal imaging or compromise visual acuity
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 |
|---|---|---|
| green subthreshold laser therapyThe intervention consists of green subthreshold laser therapy delivered using the Norlase µSec™ Technology, a novel microsecond-pulsed laser platform specifically designed for retinal treatments. | Procedure or surgery | – |
Primary outcome
change in central foveal thickness
Time frame: 3 months
to evaluate changen in Central foveal tickness (CFT), assessed on OCT images by manually placing calipers between the internal limiting membrane and the outer boundary of the retinal pigment epithelium, before and after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Derived from this study: PubMed 42526611Cennamo G, Rinaldi M, Passaro ML, Senese I, D'Aponte A, Costagliola C. Green subthreshold laser for chronic central serous chorioretinopathy: A new therapeutic approach. Photodiagnosis Photodyn Ther. 2026 Jul 29;61:105592. doi: 10.1016/j.pdpdt.2026.105592. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 the Presence of Subretinal Fluid (SRF), run by Federico II University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in central foveal thickness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07020793, which also lists 1 linked publication.
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 13 Jun 2025.