UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058902 |
|---|---|
| Receipt number | R000067362 |
| Scientific Title | A retrospective observational study to investigate the impact of the severity of ptosis on visual functions |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/26 16:34:05 |
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Basic information
Public title
A retrospective observational study to investigate the impact of the severity of ptosis on visual functions
Acronym
A retrospective observational study to investigate the impact of the severity of ptosis on visual functions
Scientific Title
A retrospective observational study to investigate the impact of the severity of ptosis on visual functions
Scientific Title:Acronym
A retrospective observational study to investigate the impact of the severity of ptosis on visual functions
Region
| Japan |
Condition
Condition
Ptosis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily investigate the impact of the severity of ptosis on visual functions in patients with ptosis through a retrospective observational study.
Basic objectives2
Others
Basic objectives -Others
To exploratorily investigate the impact of the severity of ptosis on visual functions in patients with ptosis through a retrospective observational study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the degree of ptosis and visual functions
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ptosis who visited the study site during the study period (June 2025 - August 2025) who met all of the following criteria will be eligible.
1) 18 years of age or older (at the time of visit)
2) MRD-1, visual acuity, refraction, visual field, contrast sensitivity, and higher-order aberration measured on the same day for the right eye
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Miyahara |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Fuwa |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asai Dermatology Institutional Review Board
Address
1-14, Katabira-cho, Hodogaya-ku, Yokohama-shi, Kanagawa
Tel
03-5543-0196
jimukyoku@smo-msr.co.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
| 2025 | Year | 09 | Month | 01 | 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
| 2025 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study based on existing hospital medical records.
Management information
Registered date
| 2025 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067362
