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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027518
Receipt No. R000031546
Scientific Title Prospective study of AcuFocus IC-8 intraocular lens
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/28

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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
Last 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
1st 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
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
2017 Year 05 Month 28 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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