UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027518 |
|---|---|
| Receipt number | R000031546 |
| Scientific Title | Prospective study of AcuFocus IC-8 intraocular lens |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2019/06/16 20:00:25 |
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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
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
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
sawada@lasik.jp
Sponsor or person
Institute
Nagoya Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031546
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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