UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030529
Receipt number R000034852
Scientific Title Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens
Date of disclosure of the study information 2017/12/25
Last modified on 2021/01/06 11:30:59

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Basic information

Public title

Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens

Acronym

Clinical utility of extended depth of focus intraocular lens

Scientific Title

Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens

Scientific Title:Acronym

Clinical utility of extended depth of focus intraocular lens

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate clinical utility of extended depth of focus intraocular lens for eyes with irregular corneal astigmatism and eyes after refractive surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

contrast sensitivity

Key secondary outcomes

conventional visual acuity, functional visual acuity, binocular visual function
refraction, high order aberration, light scattering
QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Patient with extended depth of focus intraocular lens (ZXR00V)

Interventions/Control_2

Patient with monofocal intraocular lens (ZCB00V)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Cataract patient with irregular corneal astigmatism or after refractive surgery

Key exclusion criteria

anisometropia, strabismus, dry eye, severe glaucoma, macular disease, optic nerve disease

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yumi
Middle name
Last name Hasegawa

Organization

University of Tsukuba

Division name

Department of Ophthalmology, Faculty of Medicine,

Zip code

3058575

Address

1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan

TEL

029-853-3148

Email

ytamura-tuk@umin.ac.jp


Public contact

Name of contact person

1st name Yumi
Middle name
Last name Hasegawa

Organization

University of Tsukuba

Division name

Department of Ophthalmology, Faculty of Medicine,

Zip code

3058575

Address

1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan

TEL

029-853-3148

Homepage URL


Email

ytamura-tuk@umin.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Faculty of Medicine, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba Hospital

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

Tsukuba Clinical Research & Development Organization

Address

Amakubo 2-1-1 Tsukuba Ibaraki Japan

Tel

029-853-3914

Email

rinshokenkyu@un.tsukuba.ac.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



Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 25 Day


Related information

URL releasing protocol

https://tsukuba-eye.jp

Publication of results

Unpublished


Result

URL related to results and publications

https://tsukuba-eye.jp

Number of participants that the trial has enrolled

4

Results

There was no difference in postoperative contrast sensitivity between the symphony group and the monodical lens group.

Results date posted

2021 Year 01 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with cataract surgery for eyes with corneal astigmatism that is more than twice the standard deviation (2SD) or with a history of refractive surgery

Participant flow

The principal investigator will explain the content of this study and the characteristics of each intraocular lens to the target patients, and the patient will decide which intraocular lens to use.

Adverse events

No

Outcome measures

contrast sensitivity

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 20 Day

Date of IRB

2018 Year 01 Month 05 Day

Anticipated trial start date

2018 Year 01 Month 04 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 12 Month 22 Day

Last modified on

2021 Year 01 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034852


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name