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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020679
Receipt No. R000023864
Scientific Title Changes in refractive power and posterior corneal shape following cataract surgery
Date of disclosure of the study information 2016/02/01
Last modified on 2016/04/06

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Basic information
Public title Changes in refractive power and posterior corneal shape following cataract surgery
Acronym posterior corneal shape following cataract surgery
Scientific Title Changes in refractive power and posterior corneal shape following cataract surgery
Scientific Title:Acronym posterior corneal shape following cataract surgery
Region
Japan

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

Objectives
Narrative objectives1 To investigate the correlation between refractive changes and posterior corneal power changes following cataract surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative data (visual acuity, refractive error, wavefront aberration, corneal topography, anterior chamber depth)
Key secondary outcomes lens opacity, corneal endothelial cell density, operative data (ultrasound time, cumulative dissipated energy)

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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients receiving cataract surgery
Key exclusion criteria Patients with corneal disease, high myopia, severe cataract and intraoperative complication
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuta Ueno
Organization University of Tsukuba
Division name Majors in Medical Sciences
Zip code
Address 1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL 0298533148
Email yu_ueno71@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuta Ueno
Organization University of Tsukuba
Division name Majors in Medical Sciences
Zip code
Address 1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL 0298533148
Homepage URL
Email yu_ueno71@yahoo.co.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 筑波大学付属病院(茨城県)、海谷眼科(愛知県)、かけ川海谷眼科(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Prospective study
Subjects: Patients receiving cataract surgery from February 1, 2016 to November 30, 2017
Main outcome measures: Postoperative data (visual acuity, refractive error, wavefront aberration, corneal topography, anterior chamber depth)

Management information
Registered date
2016 Year 01 Month 21 Day
Last modified on
2016 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023864

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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