Central Serous ChorioretinopathyNCT06468540
Combination of Micropulse Laser With or Without Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
An observational study of Central Serous Chorioretinopathy and Micropulse Laser, run by Beijing Hospital.
Trial summary
In this study, patients with chronic central serous chorioretinopathy who were treated by micropulse laser alone or micropulse laser combined with photodynamic therapy without drugs are retrospectively included. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Serous Chorioretinopathy, Micropulse Laser, Photodynamic Therapy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient diagnosed with chronic central serous chorioretinopathy with a history of more than 6 months, who received single micropulse laser therapy or micropulse laser combined with drug-free photodynamic therapy.
Who may be able to join
- Age >18 years old.
- The patient diagnosed with chronic central serous chorioretinopathy with a history of more than 6 months. The diagnostic criteria for chronic CSC were as follows: FFA examination showed leakage of strong fluorescent spots with the extension of angiography time, and late fluorescence accumulation, accompanied by decreased central vision, darkening of vision, and deformable microopia. Fundus examination showed superficial detachment of retinal neuroepithelium in macula.
- Patients received single micropulse laser therapy or micropulse laser combined with drug-free photodynamic therapy, and had not received other laser or surgical treatment in the six months prior to treatment.
- Patients had follow-up data before and after treatment for 1 month and at least 6 months.
Who cannot join
- Patients with other fundus diseases or refractive interstitial opacity.
- During treatment, other treatments other than micropulse laser or drug-free photodynamic therapy were received.
- Various reasons led to incomplete patient data.
About this study
Official title: Comparative Study on the Efficacy of the Combination of Micropulse Laser With or Without Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinal Disease
In this study, patients with chronic central serous chorioretinopathy who were treated by micropulse laser alone or micropulse laser combined with photodynamic therapy without drugs are retrospectively included. The visual acuity changes, subretinal fluid absorption and choroidal characteristics of the two groups are compared 1 to 6 months after treatment. We will also analyze baseline characteristics that influence post-treatment outcomes to identify potential predictors of poor treatment outcomes.
- Medical subject headings
- Central Serous Chorioretinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Best-corrected visual acuity using logMAR
Measured: 1 month and 6 months
CRT
Central retinal thickness on OCT
Measured: 1 month and 6 months
Secondary outcomes (1)
SFCT
subfoveal choroidal thickness on OCTA
Measured: 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Dec 2025 (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.
- 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468540
- Sponsor's protocol ID
- IIT-2024-04-376
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy of the Combination of Micropulse Laser With or Without Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinal Disease
- ClinicalTrials.gov ID
- NCT06468540
- Acronym / sponsor ID
- IIT-2024-04-376
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 21 Jun 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.
In this study, patients with chronic central serous chorioretinopathy who were treated by micropulse laser alone or micropulse laser combined with photodynamic therapy without drugs are retrospectively included. The visual acuity changes, subretinal fluid absorption and choroidal characteristics of the two groups are compared 1 to 6 months after treatment. We will also analyze baseline characteristics that influence post-treatment outcomes to identify potential predictors of poor treatment outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient diagnosed with chronic central serous chorioretinopathy with a history of more than 6 months, who received single micropulse laser therapy or micropulse laser combined with drug-free photodynamic therapy.
Key inclusion criteria (4 listed)
- Age >18 years old.
- The patient diagnosed with chronic central serous chorioretinopathy with a history of more than 6 months. The diagnostic criteria for chronic CSC were as follows: FFA examination showed leakage of strong fluorescent spots with the extension of angiography time, and late fluorescence accumulation, accompanied by decreased central vision, darkening of vision, and deformable microopia. Fundus examination showed superficial detachment of retinal neuroepithelium in macula.
- Patients received single micropulse laser therapy or micropulse laser combined with drug-free photodynamic therapy, and had not received other laser or surgical treatment in the six months prior to treatment.
- Patients had follow-up data before and after treatment for 1 month and at least 6 months.
Key exclusion criteria (3 listed)
- Patients with other fundus diseases or refractive interstitial opacity.
- During treatment, other treatments other than micropulse laser or drug-free photodynamic therapy were received.
- Various reasons led to incomplete patient data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BCVA
Time frame: 1 month and 6 months
Best-corrected visual acuity using logMAR
CRT
Time frame: 1 month and 6 months
Central retinal thickness on OCT
1 secondary outcome
SFCT
Time frame: 1 month and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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?
An observational study of Central Serous Chorioretinopathy and Micropulse Laser, 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 4 inclusion and 3 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 21 Jun 2024. 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?
BCVA (time frame: 1 month and 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?
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 21 Jun 2024.