UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens after Monofocal Intraocular Lens Implantation.
Acronym	Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens.
Scientific Title	Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens after Monofocal Intraocular Lens Implantation.
Scientific Title:Acronym	Comparison of Visual Performance and Patient Satisfaction after Multifocal Intraocular Lens Implantation and Multifocal Contact Lens.
Region	Japan

Condition
Condition	Presybyopia after Cataract Surgery
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess visual performance and patient satisfaction of multifocal contact lenses in eyes having monofocal intraocular lens (IOL) implantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity at all distances, Contrast sensitivity function.
Key secondary outcomes

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	40 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Eyes with corneal astigmatism of 1.5 diopter (D) or less Eyes with postoperative best corrected visual acuity of 0.1 logMAR or better
Key exclusion criteria	Eyes with any history of ocular surgery, ocular trauma, or other concomitant eye diseases Eyes developing any intraoperative or postoperative complications
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kamiya Middle name Last name Kazutaka
Organization	Kitasato University
Division name	School of Allied Health Sciences
Zip code	2520373
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	1st name Kamiya Middle name Last name Kazutaka
Organization	Kitasato University
Division name	School of Allied Health Sciences
Zip code	2520373
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Homepage URL
Email	kamiyak-tky@umin.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
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	Miyata Eye Hospital
Address	6-3, Kurahara, Miyakonojo, Miyazaki
Tel	0986-22-1441
Email	kamiyak-tky@umin.ac.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

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/34705259/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/34705259/
Number of participants that the trial has enrolled	142
Results	both multifocal IOLs and CLs provided good near-to-distance binocular vision and subsequent high patient satisfaction in daily activities with acceptable contrast sensitivity.
Results date posted	2022 Year 08 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	multifocal intraocular lens (IOL)-implanted eyes and multifocal contact lens (CL)-wearing eyes undergoing monofocal IOL implantation.
Participant flow	retrospectiver review of the clinical charts.
Adverse events	No significant complications
Outcome measures	visual acuity at all distances (0.3, 0.5, 0.7, 1, and 5 m), contrast sensitivity function, patient satisfaction score, and the rate of spectacle independence
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 01 Month 01 Day
Date of IRB	2021 Year 02 Month 25 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To determine visual acuity at all distances (0.3, 0.5, 0.7, 1, and 5 m), contrast sensitivity (CS) function, patient satisfaction, and the independence of spectacle correction, in both the multifocal IOL and multifocal CL groups.

Management information
Registered date	2021 Year 08 Month 12 Day
Last modified on	2022 Year 08 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051561