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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034758
Receipt No. R000039639
Official scientific title of the study Quantitative Analysis of Objective Forward Scattering and Its Relevant Factors in Eyes with Cataract.
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/03

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Basic information
Official scientific title of the study Quantitative Analysis of Objective Forward Scattering and Its Relevant Factors in Eyes with Cataract.
Title of the study (Brief title) Objective forward scattering for cataract.
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To quantitatively assess objective forward scattering and its relevant factors in eyes having cataract.
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective Forward Scattering
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Cataractous patients who completed all optical examinations for cataract surgery consultation.
Key exclusion criteria patients who had other ophthalmic diseases.
Target sample size 180

Research contact person
Name of lead principal investigator Kamiya Kazutaka
Organization Kitasato University
Division name School of Allied Health Sciences
Address 1-15-1, Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Email kamiyak-tky@umin.ac.jp

Public contact
Name of contact person Kamiya Kazutaka
Organization Kitasato University
Division name School of Allied Health Sciences
Address 1-15-1, Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Homepage URL
Email kamiyak-tky@umin.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Kitasato University

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information We determine uncorrected and corrected distance visual acuities (UDVA and CDVA), manifest refraction, the grade of nuclear sclerosis, objective scattering index (OSI) with the OQAS II (Visiometrics, Spain), log(s) with the C-Quant (Oculus, Germany), and ocular higher-order aberrations (HOAs) with the wavefront sensor (KR-1W, Topcon, Japan). We utilize single and multiple regression analyses to evaluate the factors relevant to the OSI in such eyes.

Management information
Registered date
2018 Year 11 Month 03 Day
Last modified on
2018 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039639

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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