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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027109
Receipt No. 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 2019/10/09

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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
Email 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
Email mihashi@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 15 Day
Date of IRB
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
2019 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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