UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027109 |
|---|---|
| Receipt number | R000030893 |
| Scientific Title | Evaluation of measurement performance of ophthalmic instruments with crystalline lens opacity |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2020/03/19 20:17:11 |
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Basic information
Public title
Evaluation of measurement performance of ophthalmic instruments with crystalline lens opacity
Acronym
Evaluation of performance of ophthalmic instruments with lens opacity
Scientific Title
Evaluation of measurement performance of ophthalmic instruments with crystalline lens opacity
Scientific Title:Acronym
Evaluation of performance of ophthalmic instruments with lens opacity
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the performance of several autorefractometers for measuring cataractous eyes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluating the performance of several autorefractometers for measuring cataractous eyes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Comparison of results between the developint instrument and three instruments certified in the Pharmaceutical Affairs Law
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cataract patients
Key exclusion criteria
Patients with retinal disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
0298533148
oshika@eye.ac
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Mihashi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
0298533148
Homepage URL
mihashi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Topcon Coporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Topcon Coporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
0298533148
mihashi@md.tsukuba.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
筑波大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 24 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030893
