UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035400
Receipt number R000040336
Scientific Title Comparison between blue-blocking and violet-blocking intraocular lenses.
Date of disclosure of the study information 2018/12/29
Last modified on 2019/06/30 15:35:17

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Basic information

Public title

Comparison between blue-blocking and violet-blocking intraocular lenses.

Acronym

Comparison of blue-blocking and violet-blocking IOLs

Scientific Title

Comparison between blue-blocking and violet-blocking intraocular lenses.

Scientific Title:Acronym

Comparison of blue-blocking and violet-blocking IOLs

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Prospective comparison of surgical outcomes between blue-blocking and violet-blocking intraocular lenses

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual functions at 1 year postoperatively

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Cataract surgery using blue-blocking intraocular lenses

Interventions/Control_2

Cataract surgery using violet-blocking intraocular lenses

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

Eligible for standard cataract surgery

Key exclusion criteria

Those having diseases which affect visual functions

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tetsuro
Middle name
Last name Oshika

Organization

University of Tsukuba

Division name

Department of Opohthalmology

Zip code

305-8575

Address

1-1-1 Tennoudai, Tsukuba, Ibaraki

TEL

029-853-3148

Email

oshika@eye.ac


Public contact

Name of contact person

1st name Tetsuro
Middle name
Last name Oshika

Organization

University of Tsukuba

Division name

Department of Ophthalmology

Zip code

305-8575

Address

1-1-1 Tennoudai, Tsukuba, Ibaraki

TEL

029-853-3148

Homepage URL


Email

oshika@eye.ac


Sponsor or person

Institute

Division of Ophthalmology, Ryugasaki Saiseikai Hospital

Institute

Department

Personal name



Funding Source

Organization

Division of Ophthalmology, Ryugasaki Saiseikai 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

University of Tsukuba

Address

1-1-1 Tennoudai, Tsukuba

Tel

029-853-3

Email

oshika@eye.ac


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

2018 Year 12 Month 29 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

Completed

Date of protocol fixation

2018 Year 12 Month 29 Day

Date of IRB

2018 Year 01 Month 10 Day

Anticipated trial start date

2019 Year 01 Month 10 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

2018 Year 12 Month 29 Day

Last modified on

2019 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040336


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name