Central Serous ChorioretinopathyNCT05687422
Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
A study testing 100μm laser spot diameter micropulse laser and 200μm laser spot diameter micropulse laser in people with Central Serous Chorioretinopathy, run by Beijing Hospital.
Trial summary
Central serous chorioretinopathy (CSC) is a common eye disease mainly involving the macular area, causing central visual acuity loss. Recently, subthreshold micropulse laser used in treating chronic CSC is proved to be safe and effective. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- 100μm laser spot diameter micropulse laser and 200μm laser spot diameter micropulse laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Dec 2023
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age range 18-50 years
- Patients diagnosed with chronic Central serous chorioretinopathy
- Patients have signed informed consent
Who cannot join
- A history of other fundus diseases or refractive media opacity
- Patients have underwent other treatment methods for chronic Central serous chorioretinopathy
- Diopter>-6D
- A history of system diseases such as hypertension or diabetes
- A history of using local or systemic corticosteroids
About this study
Official title: A Randomized Controlled Study of Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
Central serous chorioretinopathy (CSC) is a common eye disease mainly involving the macular area, causing central visual acuity loss. Recently, subthreshold micropulse laser used in treating chronic CSC is proved to be safe and effective. However, some studies indicate that it's less effective than half dose photodynamic therapy (PDT). Certain physicians, including us, think that this may be related to micropulse laser parameters. Thus we need to explore better laser patterns to replace PDT in treating chronic CSC. The aim of this study is to compare the treatment effect of two different patterns of laser parameters (small and regular spot diameter) in treating chronic CSC. In this randomized, double blinded, controlled trial, by comparing the subretinal fluid regression ratio, central retinal thickness, macular microvisual field, macular vascular density, chroidal volume changes and visual acuity of two groups 6 months after micropulse laser treatment, we aim to evaluate the safety and efficacy of refined micropulse laser in treating chronic CSC.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- 100μm laser spot diameter micropulse laser, 200μm laser spot diameter micropulse laser
- 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.
100μm laser spot diameter micropulse laserProcedure or surgery
100μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months
200μm laser spot diameter micropulse laserProcedure or surgery
200μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 100μm laser spot diameter group | Experimental | Not described Receives: Procedure: 100μm laser spot diameter micropulse laser |
| 200μm laser spot diameter group | Active comparator | Not described Receives: Procedure: 200μm laser spot diameter micropulse laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subretinal fluid regression ratio
Comparing the subretinal fluid regression ratio of two groups at 6 months follow-up
Measured: 6 months
Central retinal thickness changes
Comparing the central retinal thickness changes of two groups at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yu Xiaobing, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687422
- Sponsor's protocol ID
- 2021-I2M-C&T-B-093
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Wang J, Liu J, Gu X, Song S, Yu X. Three-dimensional choroidal characteristics in different subtypes of central serous chorioretinopathy using swept-source optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2025 Mar;263(3):689-697. doi: 10.1007/s00417-024-06691-8. Epub 2024 Nov 19.
PubMed 39557692
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT05687422
- Acronym / sponsor ID
- 2021-I2M-C&T-B-093
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Jan 2023 (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.
Central serous chorioretinopathy (CSC) is a common eye disease mainly involving the macular area, causing central visual acuity loss. Recently, subthreshold micropulse laser used in treating chronic CSC is proved to be safe and effective. However, some studies indicate that it's less effective than half dose photodynamic therapy (PDT). Certain physicians, including us, think that this may be related to micropulse laser parameters. Thus we need to explore better laser patterns to replace PDT in treating chronic CSC. The aim of this study is to compare the treatment effect of two different patterns of laser parameters (small and regular spot diameter) in treating chronic CSC. In this randomized, double blinded, controlled trial, by comparing the subretinal fluid regression ratio, central retinal thickness, macular microvisual field, macular vascular density, chroidal volume changes and visual acuity of two groups 6 months after micropulse laser treatment, we aim to evaluate the safety and efficacy of refined micropulse laser in treating chronic CSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100μm laser spot diameter group | Experimental | Procedure: 100μm laser spot diameter micropulse laser |
| 200μm laser spot diameter group | Active comparator | Procedure: 200μm laser spot diameter micropulse laser |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients age range 18-50 years
- Patients diagnosed with chronic Central serous chorioretinopathy
- Patients have signed informed consent
Key exclusion criteria (5 listed)
- A history of other fundus diseases or refractive media opacity
- Patients have underwent other treatment methods for chronic Central serous chorioretinopathy
- Diopter>-6D
- A history of system diseases such as hypertension or diabetes
- A history of using local or systemic corticosteroids
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 |
|---|---|---|
| 100μm laser spot diameter micropulse laser100μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months | Procedure or surgery | 100μm laser spot diameter group |
| 200μm laser spot diameter micropulse laser200μm laser spot diameter micropulse laser at baseline, then follow-up for 6 months | Procedure or surgery | 200μm laser spot diameter group |
Primary outcome
Subretinal fluid regression ratio
Time frame: 6 months
Comparing the subretinal fluid regression ratio of two groups at 6 months follow-up
Central retinal thickness changes
Time frame: 6 months
Comparing the central retinal thickness changes of two groups at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 39557692Zhang Y, Wang J, Liu J, Gu X, Song S, Yu X. Three-dimensional choroidal characteristics in different subtypes of central serous chorioretinopathy using swept-source optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2025 Mar;263(3):689-697. doi: 10.1007/s00417-024-06691-8. Epub 2024 Nov 19.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 100μm laser spot diameter micropulse laser and 200μm laser spot diameter micropulse laser in people with Central Serous Chorioretinopathy, run by Beijing Hospital.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Subretinal fluid regression ratio (time frame: 6 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?
On the ClinicalTrials.gov record for NCT05687422, 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 18 Jan 2023.