UMIN-CTR Clinical Trial

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