UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012412 |
|---|---|
| Receipt number | R000014470 |
| Scientific Title | A prospective observational study of structure and visual field age-related progression in normal eye |
| Date of disclosure of the study information | 2013/11/29 |
| Last modified on | 2022/03/10 16:10:41 |
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Basic information
Public title
A prospective observational study of structure and visual field age-related progression in normal eye
Acronym
A prospective observational study of structure and visual field age-related progression in normal eye
Scientific Title
A prospective observational study of structure and visual field age-related progression in normal eye
Scientific Title:Acronym
A prospective observational study of structure and visual field age-related progression in normal eye
Region
| Japan |
Condition
Condition
Normal eyes
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate progression and correlation of structure and visual field in normal eye
Basic objectives2
Others
Basic objectives -Others
Structure and visual field age-related progression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MD
Retinal nerve fiber layer
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subject who is willing to follow instruction, and has provided a written informed consent
In both eyes, gonioscopy grading of 3 or 4 in Shaffer classification
Key exclusion criteria
Subject who has a disease which considered difficult to perticipate study
The investigator, subinvestigator determined that the person is ineligible as study subject
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Iwase |
Organization
Tajimi Iwase Eye Clinic
Division name
Tajimi Iwase Eye Clinic
Zip code
507-0033
Address
3-101-1, Honmachi Tajimishi Gifu Japan
TEL
0572-25-1221
aiko-gif@umin.net
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Kawata |
Organization
Santen Pharmaceutical CO., LTD.
Division name
Clinical Development Group
Zip code
530-8552
Address
4-20, Ofukacho Kita-ku Osaka Japan
TEL
06-4802-9338
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
Kanto Central Hospital Ethics Committee
Address
6-25-1 Kamiyoga, Setagaya-ku, Tokyo
Tel
03-3429-1171
saitohitomi-oph@umin.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
| 2013 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
38
Results
Age-related changes in the sensitivity of the visual field were not detected in Fovea.There were differences by location, more pronounced in the lower hemifield than in the upper hemifield, and in the central field than in the peripheral field.
The older the age, the greater the annual decline tended to be, but this trend was not observed in the periphery.
The higher the original sensitivity, the greater the tendency.
Results date posted
| 2022 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable due to observational study
Participant flow
Not applicable due to observational study
Adverse events
Not applicable due to observational study
Outcome measures
Not applicable due to observational study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study
Management information
Registered date
| 2013 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014470
