UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031588
Receipt number 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 2021/03/08 10:09:20

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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 Kazuo
Middle name
Last name Ichikawa

Organization

Chukyo Eye Clinic

Division name

Vision Research Laboratory

Zip code

456-0032

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 Yukihiro
Middle name
Last name Sakai

Organization

Chukyo Eye Clinic

Division name

Orthoptist

Zip code

456-0032

Address

12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi

TEL

052-883-1543

Homepage URL


Email

sakai@chukyo-eyeclinic.jp


Sponsor or person

Institute

Chukyo Eye Clinic
Vision Research Laboratory

Institute

Department

Personal name



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

Chukyo Medical, IRB

Address

Sanbonmatsu-cho, Atsuta-ku, Nagoya-city, Aichi

Tel

052-884-7976

Email

irb@chukyomedical.co.jp


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

0

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

Terminated

Date of protocol fixation

2018 Year 03 Month 05 Day

Date of IRB

2018 Year 02 Month 26 Day

Anticipated trial start date

2018 Year 03 Month 05 Day

Last follow-up date

2021 Year 03 Month 08 Day

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

2021 Year 03 Month 08 Day



Link to view the page

Value
https://center6.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