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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031588
Receipt No. R000036067
Scientific Title Examination of cataract treatment result using multi-focal intraocular lens called Mini WELL Ready.
Date of disclosure of the study information 2018/03/05
Last modified on 2018/03/05

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Basic information
Public title Examination of cataract treatment result using multi-focal intraocular lens called Mini WELL Ready.
Acronym Postoperative result examination of multi-focal intraocular lens called Mini WELL Ready.
Scientific Title Examination of cataract treatment result using multi-focal intraocular lens called Mini WELL Ready.
Scientific Title:Acronym Postoperative result examination of multi-focal intraocular lens called Mini WELL Ready.
Region
Japan

Condition
Condition Age-related cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of cataract treatment result in which multi-focal intraocular lens called Mini WELL Ready was used.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual acuity test 1 week, 1 month, 3 months, 6 months after the surgery(at 5m, 70cm, 40cm), objective and subjective refractive value, questionnaire evaluation(presence of glare, halo), intraocular pressure, number of corneal endothelial cell
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 One intraocular lens will be inserted into one eye. Observation period is up to 6 months after the surgery.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among the patients who are willing to have cataract surgery, patient volunteered to have multifocal intraocular lens Mini WELL Ready implant.
Key exclusion criteria Fundus disease
Glaucoma
Corneal irregular astigmatism (including corneal disease such as conical cornea, etc.)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Ichikawa
Organization Chukyo Eye Clinic
Division name Vision Research Laboratory
Zip code
Address 12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL 052-883-1543
Email ichikawa@chukyogroup.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Sakai
Organization Chukyo Eye Clinic
Division name Orthoptist
Zip code
Address 12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL 052-883-1543
Homepage URL
Email sakai@chukyo-eyeclinic.jp

Sponsor
Institute Chukyo Eye Clinic
Vision Research Laboratory
Institute
Department

Funding Source
Organization Chukyo Eye Clinic
Vision Research Laboratory
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Chukyo Eye Clinic
Yuya Sato Eye Clinic
Hoshino Eye Clinic
Tomita Eye Clinic
Oka Eye Clinic
Chayagasaka Eye Clinic
Nakamura Eye Clinic
Tomiyasu Eye Clinic
Okegawa Eye Clinic
Kobayashi Eye 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 中京眼科(愛知県)
佐藤裕也眼科(宮城県)
ほしの眼科 (愛知県)
冨田眼科クリニック (愛知県)
岡眼科 (福岡県)
茶屋ヶ坂眼科クリニック(愛知県)
中村眼科 (長野県)
冨安眼科 (愛知県)
おけがわ眼科 (埼玉県)
小林眼科(山口県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 05 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
2018 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036067

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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