UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037400
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Hayashi Eye Hospital
Institute
Department

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
URL(English) https://upload.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


Contact us.