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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035630
Receipt No. R000040590
Scientific Title Performance comparison among different intraocular lenses in cataract surgery
Date of disclosure of the study information 2019/02/19
Last modified on 2019/03/06

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Basic information
Public title Performance comparison among different intraocular lenses in cataract surgery
Acronym Performance comparison among the different intraocular lenses in cataract surgery
Scientific Title Performance comparison among different intraocular lenses in cataract surgery
Scientific Title:Acronym Performance comparison among the different intraocular lenses in cataract surgery
Region
Japan

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

Objectives
Narrative objectives1 Performance comparison among different intraocular lenses in cataract surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes uncorrected visual acuity, corrected visual acuity, reflection, aberration, parameters of anterior part of the eye, post-operative halo, glare, starburst, patient satisfaction, frequency of eyeglass use
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
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients who had cataract surgery and agreed to participate in the study by written informed consent
Key exclusion criteria Patients who had cataract surgery but did not agree to participate in the study by written informed consent
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Tanabe
Organization Saneikai Tsukazaki Hospital
Division name Department of Ophthalmology
Zip code
Address Himeji City aboshi waku 68-1
TEL 0792-98-8555
Email tennsyoudragon@icloud.com

Public contact
Name of contact person
1st name
Middle name
Last name Hirotaka Tanabe
Organization Saneikai Tsukazaki Hospital
Division name Department of Ophthalmology
Zip code
Address Himeji City aboshi waku 68-1
TEL 0792-98-8555
Homepage URL
Email tennsyoudragon@icloud.com

Sponsor
Institute Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 19 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
2019 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Performance comparison among different intraocular lenses in cataract surgery

Management information
Registered date
2019 Year 01 Month 23 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040590

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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