Central Serous Retinopathy (CSR)NCT07889518
Treatment of Recurrent and Multifocal Central Serous Chorioretinopathy
A study testing 577 nm Subthreshold Micropulse Laser in people with Central Serous Retinopathy (CSR) and Sub-Threshold Laser, run by Benha University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if subthreshold micropulse laser is a safe, effective, and painless treatment for multifocal and recurrent central serous chorioretinopathy (CSCR) in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Retinopathy (CSR), Sub-Threshold Laser
- What is being tested?
- 577 nm Subthreshold Micropulse Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 May 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 to 60 years
- Diagnosis of multifocal or recurrent central serous chorioretinopathy (CSCR)
- Presence of subretinal fluid involving the macula on spectral-domain OCT
- Leakage confirmed on fluorescein angiography
- Persistent subretinal fluid for more than 3 months or at least one previous episode of CSCR
- Willingness to attend all follow-up visits
Who cannot join
- Choroidal neovascularization or polypoidal choroidal vasculopathy
- Previous treatment with thermal laser, photodynamic therapy, or intravitreal injections in the study eye within the last 6 months
- Other macular diseases such as diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, or macular hole
- Media opacity preventing adequate OCT imaging or laser treatment
- Current systemic or local corticosteroid use
- Pregnancy or lactation
- History of intraocular surgery in the study eye within the last 6 months
- High myopia (more than -6.00 diopters)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Painless Alternative Management of Multifocal and Recurrent Central Serous Chorioretinopathy (CSCR)
The goal of this clinical trial is to learn if subthreshold micropulse laser is a safe, effective, and painless treatment for multifocal and recurrent central serous chorioretinopathy (CSCR) in adults.
The main questions it aims to answer are:
Read more
- Does subthreshold micropulse laser reduce the fluid under the retina, as measured by optical coherence tomography (OCT)?
- Does it improve vision and lower the chance of the disease coming back?
Participants will:
- Have a full eye examination, including vision testing, OCT, and fluorescein angiography before treatment.
- Receive subthreshold micropulse laser treatment, which is painless and does not damage the retina.
- Return for follow-up visits at 1, 3, and 6 months for vision testing and OCT scans.
- Receive a repeat laser session at 3 months if fluid is still present.
Read the detailed description
Background:
Central serous chorioretinopathy (CSCR) is a common retinal disease characterized by serous detachment of the neurosensory retina, associated with choroidal hyperpermeability and retinal pigment epithelium (RPE) dysfunction. While acute CSCR often resolves spontaneously, multifocal and recurrent forms are associated with persistent subretinal fluid, progressive RPE damage, photoreceptor loss, and permanent visual impairment. Conventional thermal laser photocoagulation may cause pain, retinal scarring, scotoma, and choroidal neovascularization, while photodynamic therapy (PDT) is limited by cost, verteporfin availability, and potential choroidal ischemia. Subthreshold micropulse laser delivers energy in short repetitive pulses that stimulate the RPE without causing thermal damage or pain, making it a promising alternative for multifocal and recurrent CSCR.
Objective:
To evaluate the efficacy and safety of 577 nm subthreshold micropulse laser as a painless alternative treatment for multifocal and recurrent CSCR.
Study Design:
This is a prospective, single-arm interventional study conducted at the Ophthalmology Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt. The study was approved by the Research Ethics Committee of the Faculty of Medicine, Al-Azhar University (Approval No. Ophth._40/2024). Written informed consent will be obtained from all participants.
Participants:
40 eyes of patients diagnosed with multifocal or recurrent CSCR with persistent subretinal fluid, confirmed by clinical examination, spectral-domain OCT, and fluorescein angiography.
Intervention:
All eyes will receive 577 nm yellow subthreshold micropulse laser using a 5% duty cycle, 200 ms exposure duration, and 160 µm spot size, applied in a confluent pattern over the area of leakage and subretinal fluid identified on fluorescein angiography and OCT. Power will be titrated individually to a subthreshold level with no visible retinal burn. Treatment will be repeated at 3 months if subretinal fluid persists.
Assessments:
At baseline and at each follow-up visit (1, 3, and 6 months), patients will undergo:
- Best-corrected visual acuity (BCVA) measured in logMAR
- Slit-lamp and dilated fundus examination
- Spectral-domain OCT to measure subretinal fluid height and central macular thickness (CMT)
- Fluorescein angiography when indicated
- Pain assessment during treatment using a visual analogue scale (VAS)
- Recording of any adverse events
Outcomes:
The primary outcome is the change in central macular thickness and subretinal fluid height on OCT at 3 months. Secondary outcomes include change in BCVA, rate of complete subretinal fluid resolution, recurrence rate at 6 months, pain score during treatment, and treatment-related complications.
Statistical Analysis:
Data will be analyzed using SPSS version 26. Quantitative data will be presented as mean ± SD and compared using the paired t-test or Wilcoxon signed-rank test as appropriate. Categorical data will be presented as numbers and percentages. A p-value < 0.05 will be considered statistically significant.
- Being tested
- 577 nm Subthreshold Micropulse Laser
- Keywords
- Central serous chorioretinopathy, Recurrent CSCR, Optical Coherence Tomography
- 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.
577 nm Subthreshold Micropulse LaserDevice
577 nm yellow subthreshold micropulse laser delivered with a 5% duty cycle, 200 ms exposure duration, and 160 µm spot size, applied confluently over the area of leakage identified on fluorescein angiography and the area of subretinal fluid on OCT. Power is titrated individually to a subthreshold level producing no visible retinal burn. The procedure is painless and performed under topical anesthesia with a contact lens.
| Study group | Role | What they receive |
|---|---|---|
| Subthreshold Micropulse Laser | Experimental | Patients with multifocal or recurrent central serous chorioretinopathy will receive 577 nm yellow subthreshold micropulse laser applied in a confluent pattern over the area of leakage and subretinal fluid. Treatment will be repeated at 3 months if subretinal fluid persists. Receives: Device: 577 nm Subthreshold Micropulse Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Macular Thickness
Change in central macular thickness (in micrometers) measured by spectral-domain optical coherence tomography from baseline.
Measured: Baseline, 1 and 3 months
Change in Subretinal Fluid Height
Change in maximum subretinal fluid height (in micrometers) measured by spectral-domain OCT from baseline.
Measured: Baseline, 1, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jul 2024
- Primary completion1 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous Retinopathy (CSR)Studies of the same condition, open and under way.
- More trials run by Benha 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive 577 nm subthreshold micropulse laser treatment and will be followed up for 6 months.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889518
- Sponsor's protocol ID
- Ophth._40/2024
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Painless Alternative Management of Multifocal and Recurrent Central Serous Chorioretinopathy (CSCR)
- ClinicalTrials.gov ID
- NCT07889518
- Acronym / sponsor ID
- Ophth._40/2024
- Keywords
- Central serous chorioretinopathy, Recurrent CSCR, Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 22 Oct 2026 (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.
The goal of this clinical trial is to learn if subthreshold micropulse laser is a safe, effective, and painless treatment for multifocal and recurrent central serous chorioretinopathy (CSCR) in adults.
The main questions it aims to answer are:
- Does subthreshold micropulse laser reduce the fluid under the retina, as measured by optical coherence tomography (OCT)?
- Does it improve vision and lower the chance of the disease coming back?
Participants will:
- Have a full eye examination, including vision testing, OCT, and fluorescein angiography before treatment.
- Receive subthreshold micropulse laser treatment, which is painless and does not damage the retina.
- Return for follow-up visits at 1, 3, and 6 months for vision testing and OCT scans.
- Receive a repeat laser session at 3 months if fluid is still present.
Detailed description
Background:
Central serous chorioretinopathy (CSCR) is a common retinal disease characterized by serous detachment of the neurosensory retina, associated with choroidal hyperpermeability and retinal pigment epithelium (RPE) dysfunction. While acute CSCR often resolves spontaneously, multifocal and recurrent forms are associated with persistent subretinal fluid, progressive RPE damage, photoreceptor loss, and permanent visual impairment. Conventional thermal laser photocoagulation may cause pain, retinal scarring, scotoma, and choroidal neovascularization, while photodynamic therapy (PDT) is limited by cost, verteporfin availability, and potential choroidal ischemia. Subthreshold micropulse laser delivers energy in short repetitive pulses that stimulate the RPE without causing thermal damage or pain, making it a promising alternative for multifocal and recurrent CSCR.
Objective:
To evaluate the efficacy and safety of 577 nm subthreshold micropulse laser as a painless alternative treatment for multifocal and recurrent CSCR.
Study Design:
This is a prospective, single-arm interventional study conducted at the Ophthalmology Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt. The study was approved by the Research Ethics Committee of the Faculty of Medicine, Al-Azhar University (Approval No. Ophth._40/2024). Written informed consent will be obtained from all participants.
Participants:
40 eyes of patients diagnosed with multifocal or recurrent CSCR with persistent subretinal fluid, confirmed by clinical examination, spectral-domain OCT, and fluorescein angiography.
Intervention:
All eyes will receive 577 nm yellow subthreshold micropulse laser using a 5% duty cycle, 200 ms exposure duration, and 160 µm spot size, applied in a confluent pattern over the area of leakage and subretinal fluid identified on fluorescein angiography and OCT. Power will be titrated individually to a subthreshold level with no visible retinal burn. Treatment will be repeated at 3 months if subretinal fluid persists.
Assessments:
At baseline and at each follow-up visit (1, 3, and 6 months), patients will undergo:
- Best-corrected visual acuity (BCVA) measured in logMAR
- Slit-lamp and dilated fundus examination
- Spectral-domain OCT to measure subretinal fluid height and central macular thickness (CMT)
- Fluorescein angiography when indicated
- Pain assessment during treatment using a visual analogue scale (VAS)
- Recording of any adverse events
Outcomes:
The primary outcome is the change in central macular thickness and subretinal fluid height on OCT at 3 months. Secondary outcomes include change in BCVA, rate of complete subretinal fluid resolution, recurrence rate at 6 months, pain score during treatment, and treatment-related complications.
Statistical Analysis:
Data will be analyzed using SPSS version 26. Quantitative data will be presented as mean ± SD and compared using the paired t-test or Wilcoxon signed-rank test as appropriate. Categorical data will be presented as numbers and percentages. A p-value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive 577 nm subthreshold micropulse laser treatment and will be followed up for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Subthreshold Micropulse Laser | Experimental | Device: 577 nm Subthreshold Micropulse LaserPatients with multifocal or recurrent central serous chorioretinopathy will receive 577 nm yellow subthreshold micropulse laser applied in a confluent pattern over the area of leakage and subretinal fluid. Treatment will be repeated at 3 months if subretinal fluid persists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 20 to 60 years
- Diagnosis of multifocal or recurrent central serous chorioretinopathy (CSCR)
- Presence of subretinal fluid involving the macula on spectral-domain OCT
- Leakage confirmed on fluorescein angiography
- Persistent subretinal fluid for more than 3 months or at least one previous episode of CSCR
Key exclusion criteria (8 listed)
- Choroidal neovascularization or polypoidal choroidal vasculopathy
- Previous treatment with thermal laser, photodynamic therapy, or intravitreal injections in the study eye within the last 6 months
- Other macular diseases such as diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, or macular hole
- Media opacity preventing adequate OCT imaging or laser treatment
- Current systemic or local corticosteroid use
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 |
|---|---|---|
| 577 nm Subthreshold Micropulse Laser577 nm yellow subthreshold micropulse laser delivered with a 5% duty cycle, 200 ms exposure duration, and 160 µm spot size, applied confluently over the area of leakage identified on fluorescein angiography and the area of subretinal fluid on OCT. Power is titrated individually to a subthreshold level producing no visible retinal burn. The procedure is painless and performed under topical anesthesia with a contact lens. | Device | Subthreshold Micropulse Laser |
Primary outcome
Change in Central Macular Thickness
Time frame: Baseline, 1 and 3 months
Change in central macular thickness (in micrometers) measured by spectral-domain optical coherence tomography from baseline.
Change in Subretinal Fluid Height
Time frame: Baseline, 1, and 3 months
Change in maximum subretinal fluid height (in micrometers) measured by spectral-domain OCT from baseline.
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 22 Oct 2026.
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?
A study testing 577 nm Subthreshold Micropulse Laser in people with Central Serous Retinopathy (CSR) and Sub-Threshold Laser, run by Benha University at 1 site in Egypt.
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 6 inclusion and 8 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 22 Oct 2026. 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 Egypt. 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 Macular Thickness (time frame: Baseline, 1 and 3 months). The study lists 2 primary outcomes in all. 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 22 Oct 2026.