UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Alcon multifocal contact lens on eyes after implantation of monofocal intraocular lenses
Title of the study (Brief title)	Efficacy of multifocal contact lens for eye after Efficacy of multifocal contact lens after implantation of monofocal intraocular lenses
Region	Japan

Condition
Condition	Pseudophakic eyes with monofocal intraocular lenses
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of Alcon multifocal contact lens wear on monofocal intraocular lens implanted eyes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distance, near and all distance visual acuities 1 and 3 months after multifocal contact lens wearing
Key secondary outcomes	Binocular Contrast sensitivity

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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients who has monofocal IOL implanted the capsule due to cataract surgery aged over 20 years and under 70. (2) Patients who wear SCL habitual current or used to before cataract surgery (3) Patients whose calculated power of bifocal SCL will be within the test CL power. (4) Patients with distance corrective vision is 0.8 or over (5) Patients who willing to be available for the follow-up observation after SCL prescription. Note: It is advised to consider carefully for the adaption of the below patients (1) Who has a refractive surgery history of LASIK, PRK, LRI and so on. (2) Corneal endothelial cell density if less than 1,500/mm2 (3) Glaucoma (4) History of uveitis or retinal detachment (5) Diabetic retinopathy (6) Excessive myopia (7) Congenital eyelid abnormality (8) Zinn's zonule rupture (9) Case of mild secondary cataract
Key exclusion criteria	(1) Infectious diseases, inflammation, abnormalities in the anterior ocular segment, diseases contraindicated for CL wearing (2) Manifest astigmatism over 1.75D (3) Toric IOL, multifocal IOL implanted eye (4) Serious postoperative complications (5) Poorly controlled glaucoma, progressive diabetic retinopathy, active uveitis (6) Implanted multifocal IOL in one eye (7) In addition, patients who is judged inappropriate due to systemic or ophthalmologic diseases by an investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Kazunori Miyata, MD, PhD
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Address	6-3 Kurahara-cho, Miyakonojo
TEL	0986-22-1441
Email	kmiyata@miyata-med.ne.jp

Public contact
Name of contact person	Kazunori Miyata, MD, PhD
Organization	Miyata Eye Hospital
Division name	Ophthalmology
Address	6-3 Kurahara-cho, Miyakonojo
TEL	0986-22-1441
Homepage URL
Email	kmiyata@miyata-med.ne.jp

Sponsor
Institute	Miyata Eye Hospital
Institute
Department

Funding Source
Organization	Alcon
Organization
Division
Category of Funding Organization	Profit organization
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 11 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 14 Day
Anticipated trial start date	2017 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Design: cohort study Recruiting: patients who visit the hospital between October and December, 2017 and meet the inclusion criteria.

Management information
Registered date	2017 Year 11 Month 07 Day
Last modified on	2018 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034104