UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of AcuFocus IC-8 intraocular lens
Acronym	Prospective study of IC-8
Scientific Title	Prospective study of AcuFocus IC-8 intraocular lens
Scientific Title:Acronym	Prospective study of IC-8
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of IC-8 intraocular lens implantation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Uncorrected visual acuity at 3 month after surgery(far, intermediate, near)
Key secondary outcomes	Best corrected visual acuity at 3 month after surgery (far, intermediate, near)

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	Device,equipment
Interventions/Control_1	Implantation of IC-8 intraocular lens
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient have visual disturbances due to cataract. 2. Patient well understands the explanation of the study by doctor.
Key exclusion criteria	1. Recurrent anterior/posterior ocular inflammation, pupil dislocation 2. Previous history of retinal hole, proliferative diabetic retinopathy, macular diseases and retinal detachment 3. Glaucoma with poor IOP control 5. Under pregnancy, lactating, intraoperative complication including continuous intraocular bleeding, vitreous prolapse and posterior capsule rupture)
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Kojima
Organization	Nagoya Eye Clinic
Division name	Department of Ophthalmology
Zip code
Address	3F Meitetsu Kanayama Bulid., 25-1 Namiyose-cho, Atsuta-ku, Nagoya, Aichi, Japan
TEL	0120758049
Email	tkojkoj@mac.com

Public contact
Name of contact person	1st name Middle name Last name Junko Sawada
Organization	Nagoya Eye Clinic
Division name	General affairs department
Zip code
Address	3F Meitetsu Kanayama Bulid., 25-1 Namiyose-cho, Atsuta-ku, Nagoya, Aichi, Japan
TEL	0120758049
Homepage URL
Email	sawada@lasik.jp

Sponsor
Institute	Nagoya Eye Clinic
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 06 Month 01 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
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	2017 Year 05 Month 01 Day
Date of IRB	2017 Year 04 Month 15 Day
Anticipated trial start date	2017 Year 05 Month 15 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 28 Day
Last modified on	2019 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031546