- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06468540
Combination of Micropulse Laser With or Without Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
June 15, 2024 updated by: Beijing Hospital
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.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
60
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BCVA
Time Frame: 1 month and 6 months
|
Best-corrected visual acuity using logMAR
|
1 month and 6 months
|
|
CRT
Time Frame: 1 month and 6 months
|
Central retinal thickness on OCT
|
1 month and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SFCT
Time Frame: 1 month and 6 months
|
subfoveal choroidal thickness on OCTA
|
1 month and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2024
Primary Completion (Estimated)
June 15, 2025
Study Completion (Estimated)
December 15, 2025
Study Registration Dates
First Submitted
June 8, 2024
First Submitted That Met QC Criteria
June 15, 2024
First Posted (Actual)
June 21, 2024
Study Record Updates
Last Update Posted (Actual)
June 21, 2024
Last Update Submitted That Met QC Criteria
June 15, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT-2024-04-376
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Central Serous Chorioretinopathy
-
Sun Yat-sen UniversityNot yet recruitingCentral Serous Chorioretinopathy (CSC)China
-
Shiraz University of Medical SciencesRecruiting
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Sun Yat-sen UniversityCompletedAcute Central Serous ChorioretinopathyChina
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Ankara Universitesi TeknokentCompletedCentral Serous Chorioretinopathy | Chronic Central Serous ChorioretinopathyTurkey
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Leiden University Medical CenterRadboud University Medical Center; Academisch Medisch Centrum - Universiteit...UnknownChronic Central Serous ChorioretinopathyNetherlands
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Manhattan Eye, Ear & Throat HospitalAlcon Research; LuEsther T. Mertz Retinal Research CenterCompletedChronic Central Serous ChorioretinopathyUnited States
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Jin Chen-jinCompletedAcute Central Serous ChorioretinopathyChina
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Semmelweis UniversityCompletedChronic Central Serous ChorioretinopathyHungary
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Jang Won HeoNovartis Korea Ltd.CompletedChronic Central Serous ChorioretinopathyKorea, Republic of
-
Radboud University Medical CenterOogziekenhuis RotterdamRecruitingChronic Central Serous ChorioretinopathyNetherlands