UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046089 |
|---|---|
| Receipt number | R000052606 |
| Scientific Title | Influence of the optic media and its relation to retinal morphology and visual function |
| Date of disclosure of the study information | 2021/12/25 |
| Last modified on | 2024/07/25 12:05:19 |
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Basic information
Public title
Is the relationship between retinal morphology and visual function more sensitive when correcting for the effects of the optic media?
Acronym
Influence of the optic media and its relation to retinal morphology and visual function
Scientific Title
Influence of the optic media and its relation to retinal morphology and visual function
Scientific Title:Acronym
Influence of the optic media and its relation to retinal morphology and visual function
Region
| Japan |
Condition
Condition
Diseases that cause clouding of the optic media, and diseases that cause abnormal retinal morphology
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this course is to elucidate the pathogenesis of the disease by discovering characteristic relationships and findings from ophthalmic imaging and visual function tests.
Basic objectives2
Others
Basic objectives -Others
Examine changes in ophthalmic images over time and their relationship to visual function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation the retinal layer thickness obtained from optical coherence tomography with the visual field test results after correcting for the effect of the optic media and without correction, and examine the difference between them.
Key secondary outcomes
Relationship between ophthalmic image and visual function such as visual acuity and visual field, and changes in morphological and functional findings over time
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 have undergone ophthalmological examinations at our hospital for diseases that cause retinal morphological disorders (anterior retina, glaucoma, age-related macular degeneration, retinal vein occlusion, etc.), abnormalities in the optic media (cataracts, corneal disorders, etc.), or suspicion of such disorders.
Key exclusion criteria
Patients whose imaging and visual function tests were not examinable
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tomita |
Organization
Nagoya University
Division name
Ophthalmology
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
0527442275
tomitaryo@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tomita |
Organization
Nagoya University
Division name
Ophthalmology
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
0527442275
Homepage URL
tomitaryo@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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 City, Aichi Prefecture
Tel
052-744-2061
ethics(at)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
| 2021 | Year | 12 | Month | 25 | 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
In the process of collecting data
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
| 2021 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study of the relationship between intermediate translucent opacity, ophthalmic imaging findings, and visual function
Management information
Registered date
| 2021 | Year | 11 | 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=R000052606
