UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037400
Receipt number R000042618
Scientific Title Factors Affecting Changes in Refractive Prediction Error after Implant Surgery of Single-Piece Acrylic Intraocular Lens
Date of disclosure of the study information 2019/07/17
Last modified on 2019/07/17 10:48:54

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Basic information

Public title

Factors Affecting Changes in Refractive Prediction Error after Implant Surgery of Single-Piece Acrylic Intraocular Lens

Acronym

Changes in Prediction Error after Implantation of Single-Piece Acrylic Intraocular Lens

Scientific Title

Factors Affecting Changes in Refractive Prediction Error after Implant Surgery of Single-Piece Acrylic Intraocular Lens

Scientific Title:Acronym

Changes in Prediction Error after Implantation of Single-Piece Acrylic Intraocular Lens

Region

Japan


Condition

Condition

Cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess how intraocular lens (IOL) power prediction error (PE) changes after implantation of single-piece acrylic IOL.

Basic objectives2

Others

Basic objectives -Others

To examine what are predictors for the change in PE

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Arithmetic IOL power prediction error (PE)
2) absolute value of PE

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

Maneuver

Interventions/Control_1

Two-hundreds and forty eyes of 240 patients underwent small-incision cataract surgery and implantation of four types of single-piece-acrylic IOL. The IOL used were Alcon SN60WF, AMO ZCB00V, Santen W-60R and HOYA XY-1.

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

First-operated eyes of patients who were scheduled for implant surgery of four types of single-piece acrylic IOL.

Key exclusion criteria

1) any pathologies of cornea, macula, and media opacity other than cataract, 2) history of ocular inflammation and surgery, 3) marked irregular astigmatism, 4) preudoexfoliation syndrome, 5) pupillary diameter less than 5.0 mm at mydriasis, 6) possibility of amblyopia, 7) difficulty in 2 months' follow-up, 8) difficulty in examinations, 9) patient refusal

Target sample size

240


Research contact person

Name of lead principal investigator

1st name Ken
Middle name
Last name Hayashi

Organization

Hayashi Eye Hospital

Division name

Department of Ophthalmology

Zip code

812-0011

Address

4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan

TEL

092-431-1680

Email

hayashi-ken@hayashi.or.jp


Public contact

Name of contact person

1st name Ken
Middle name
Last name Hayashi

Organization

Hayashi Eye Hospital

Division name

Department of ophthalmology

Zip code

812-0011

Address

4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan

TEL

092-431-1680

Homepage URL


Email

hayashi-ken@hayashi.or.jp


Sponsor or person

Institute

Hayashi Eye Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Hayashi Eye Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Hayashi Eye Hospital

Address

4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan

Tel

092-431-1680

Email

mihara-seiya@hayashi.or.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

林眼科病院(福岡県)


Other administrative information

Date of disclosure of the study information

2019 Year 07 Month 17 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

240

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 10 Month 30 Day

Date of IRB

2018 Year 10 Month 30 Day

Anticipated trial start date

2018 Year 10 Month 30 Day

Last follow-up date

2019 Year 04 Month 16 Day

Date of closure to data entry

2019 Year 04 Month 16 Day

Date trial data considered complete

2019 Year 04 Month 16 Day

Date analysis concluded

2019 Year 04 Month 16 Day


Other

Other related information



Management information

Registered date

2019 Year 07 Month 17 Day

Last modified on

2019 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042618


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name