UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050608 |
|---|---|
| Receipt number | R000057644 |
| Scientific Title | Investigating the effects of treatment for diseases that cause visual dysfunction on the eye |
| Date of disclosure of the study information | 2023/04/05 |
| Last modified on | 2024/07/25 12:00:09 |
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Basic information
Public title
Investigating the effects of treatment for diseases that cause visual dysfunction on the eye
Acronym
Investigating the effects of treatment for diseases that cause visual dysfunction on the eye
Scientific Title
Investigating the effects of treatment for diseases that cause visual dysfunction on the eye
Scientific Title:Acronym
Investigating the effects of treatment for diseases that cause visual dysfunction on the eye
Region
| Japan |
Condition
Condition
Investigation of the effects of treatment for diseases that cause visual dysfunction on the eye.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of drug and surgical treatments for diseases that cause visual dysfunction on the eye on the eye and to identify findings that can be used to make better treatment choices.
Basic objectives2
Others
Basic objectives -Others
To determine the impact of treatment on the eye and changes in findings over time based on visual acuity, visual field and other visual function tests before and after treatment, intraocular pressure, postoperative quality of life, imaging findings, videos during the surgery etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Finding factors allows estimation of best-corrected visual acuity and visual field before and after treatment for diseases that cause visual dysfunction on the eye based on pretreatment findings and patient characteristics.
Key secondary outcomes
Finding the effects of treatment on the eye and changes in findings over time will be examined based on visual acuity, visual field and other visual function tests before and after treatment, intraocular pressure, postoperative quality of life, imaging findings, etc.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to receive treatment for endophthalmic diseases (lens disease, glaucoma, ocular inflammatory disease, vitreoretinal disease, choroidal disease, etc.) at the Department of Ophthalmology, Nagoya University Hospital between the date of approval for implementation and December 31, 2025. Patients undergoing follow-up observation with a view to future treatment are also eligible.
Gender and age are not required.
Key exclusion criteria
Patients who do not have reliable visual function tests
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Yuki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81-52-744-2275
tomitaryo@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tomita |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
81-52-744-2275
Homepage URL
tomitaryo@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
None
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 Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
+81-52-744-2275
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
| 2023 | Year | 04 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To find factors in which the best corrected visual acuity and visual field before and after treatment for diseases that cause visual dysfunction on the eye can be inferred from pretreatment findings and patient characteristics.
Management information
Registered date
| 2023 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057644
