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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040552
Receipt No. R000046286
Scientific Title Nucleus division assisted by holes drilled periphery
Date of disclosure of the study information 2020/06/01
Last modified on 2021/01/12

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Basic information
Public title Nucleus division assisted by holes drilled periphery
Acronym Hole-assisted chop technique
Scientific Title Nucleus division assisted by holes drilled periphery
Scientific Title:Acronym Hole-assisted chop technique
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of effectiveness drilling holes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes surgical time, safety, efficiency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 cataract surgery using Divide & conquer technique
Interventions/Control_2 cataract surgery using phacochop technique
Interventions/Control_3 cataract surgery using hole-assited technique
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
60 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Cataract with grade 2-3 nucleus for surgeons-in-practice
Key exclusion criteria cataract with small pupil or zonnular weakness
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Akimoto
Organization Osaka Red Cross Hospital
Division name Ophthalmology
Zip code 543-8555
Address 5-30 Fudegasakkicho, Tennojiku, Osaka
TEL 06-6774-5111
Email masayuki@akimoto3.com

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Akimoto
Organization Osaka Red Cross Hospital
Division name Ophthalmology
Zip code 543
Address 5-30 Fudegasakicho, Tennojiku, Osaka
TEL 06-6774-5111
Homepage URL
Email masayuki@akimoto3.com

Sponsor
Institute Ophthalmology, Osaka Red Cross Hospital
Institute
Department

Funding Source
Organization Ophthalmology, Osaka Red Cross Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka Red Cross Hospital
Address 5-30 Fudegasakicho, Tennnojiku, Osaka
Tel +81667745111
Email masayuki@akimoto3.com

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 大阪赤十字病院(大阪府)

Other administrative information
Date of disclosure of the study information
2020 Year 06 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 64
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 12 Month 01 Day
Date of IRB
2017 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 27 Day
Last modified on
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046286

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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