UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061197 |
|---|---|
| Receipt number | R000070030 |
| Scientific Title | Long-term outcomes of half-dose photodynamic therapy for chronic central serous chorioretinopathy. |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/08 14:23:40 |
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Basic information
Public title
Long-term outcomes of half-dose photodynamic therapy for chronic central serous chorioretinopathy.
Acronym
Examination of the long-term outcomes of hPDT for CSC
Scientific Title
Long-term outcomes of half-dose photodynamic therapy for chronic central serous chorioretinopathy.
Scientific Title:Acronym
Examination of the long-term outcomes of hPDT for CSC
Region
| Japan |
Condition
Condition
Chronic central serous chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the long-term clinical course after half-dose photodynamic therapy in patients with chronic central serous chorioretinopathy and to consider appropriate treatment options for the future.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate
Key secondary outcomes
Whether or not atrophy is present, and whether or not additional treatment is necessary.Changes in visual acuity and retinal thickness
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent treatment with half-dose photodynamic therapy between January 1, 2015 and December 31, 2020.
Key exclusion criteria
Patients with a history of intravitreal injection or vitrectomy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jyun |
| Middle name | |
| Last name | Takeuchi |
Organization
Nagoya University Hospital
Division name
ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
0527412111
jun.takeuchi622@outlook.com
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Tamura |
Organization
Nagoya University Hospital
Division name
ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
08045529195
Homepage URL
tamura.kazuma.g4@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Bioethics Review Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
Tel
0527412111
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Retrospective Cohort Study
Target Number of Cases: 20
Rationale for Case Size Setting: This study is a retrospective observational study, and no prior statistical hypothesis-based case size design was performed. The number of cases to be included was determined based on the clinical performance at our hospital, with the policy of continuously enrolling cases that met the criteria during the study period. As a result, approximately 20 cases are expected to be included.
This study is positioned as an exploratory analysis, primarily examining pre- and post-treatment changes and long-term outcomes (presence or absence of recurrence, etc.) descriptively and statistically.
Primary outcome: Visual acuity 5-10 years after half-dose photodynamic therapy for chronic central serous chorioretinopathy.
Secondary outcome: Evaluation of recurrence of serous retinal detachment, MNV, and choroidal atrophy after half-dose photodynamic therapy for chronic central serous chorioretinopathy.
Exposure/predictive factors: None.
Other information collected: Age, sex, intraocular pressure, history of eye surgery, general medical history, smoking history, central retinal thickness, central choroidal thickness.
Information collection method: Bulk extraction of data from electronic medical records.
Statistical and analytical methods: Changes in outcomes before and after treatment (visual acuity, retinal thickness, choroidal thickness, presence or absence of MNV, degree of choroidal atrophy, etc.) are statistically evaluated. For comparisons before and after treatment, a paired t-test is used if the data follows a normal distribution; otherwise, the Wilcoxon signed-rank test is used. For comparisons at multiple time points, repeated measures ANOVA is used if the data follows a normal distribution; otherwise, the Friedman test is used.
For comparisons of categorical variables, the chi-squared test or Fisher's exact test is used. The significance level is set at 5%.
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070030
