UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative outcomes of diffractive multifocal intraocular lens for juvenile cataract eye
Title of the study (Brief title)	Diffractive multifocal intraocular lens for juvenile cataract eye
Region	Japan

Condition
Condition	cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the postoperative results of multifocal diffractive IOL among young patients retrospectively.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Patient background (past history, corneal astigmatism, ocular axial length, lens opacity), uncorrected/uncorrected distance/near logMAR visual acuity at the 3 months after surgery,
Key secondary outcomes	contrast sensitivity, frequency of spectacle wearing, and additional refractive surgery were examined from clinical records

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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	19 years-old <
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	Young age ranging from19 to 39 years old (average 31.8 years old) who inserted +4.00 addition diffractive multifocal IOL (ZMA00, ZMB00: Abbott) at Tokyo Dental College Suidobashi Hospital from 2009 to 2013 during Cataract surgery.
Key exclusion criteria	Lens subluxation, irregular corneal astigmatism, corneal opacity, history of retinal detachment, glaucoma, uveitis, and diseases affectiong visual function.
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroko Bissen-Miyajima
Organization	Tokyo Dental College Suidobashi Hospital
Division name	Department of Ophthalmology
Address	Misakicho 2-9-18, Chiyoda-ku, Tokyo 101-0061
TEL	03-5275-1856
Email	bissen@tdc.ac.jp

Public contact
Name of contact person	Hiroko Bissen-Miyajima
Organization	Tokyo Dental College Suidobashi Hospital
Division name	Department of Ophthalmology
Address	Misakicho 2-9-18, Chiyoda-ku, Tokyo 101-0061
TEL	03-5275-1856
Homepage URL
Email	hirasawa@tdc.ac.jp

Sponsor
Institute	Tokyo Dental College
Institute
Department

Funding Source
Organization	Tokyo Dental College Suidobashi Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 14 Day
Anticipated trial start date	2016 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	n.c.

Management information
Registered date	2017 Year 05 Month 12 Day
Last modified on	2017 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031310