UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032185 |
|---|---|
| Receipt number | R000036711 |
| Scientific Title | Evaluation of cataract treatment result using multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2021/10/11 13:12:51 |
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Basic information
Public title
Evaluation of cataract treatment result using multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Acronym
Evaluation of postoperative result of multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Scientific Title
Evaluation of cataract treatment result using multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Scientific Title:Acronym
Evaluation of postoperative result of multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric
Region
| Japan |
Condition
Condition
Age related cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cataract treatment result of cases which multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric were implanted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Study of visual acuity test (distance of 5m, 70cm, and 40cm) 1 week, 1 month, 3 months, and 6 months after the surgery, objective and subjective refractive value, survey evaluation (glare, halo, etc.) intraocular pressure, and corneal endothelial cell count.
-For Trinova Toric implantation, astigmatic axis of IOL will be checked 1 month and 3 month after the surgery.
Key secondary outcomes
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
1 intraocular lens will be implanted in 1 eye. Eye will be observed for 6 month after the surgery.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Multifocal intraocular lens AcrivaUDReviol Trinova and Trinova Toric applicant among cataract surgery applicant.
Key exclusion criteria
Fundus disease
Glaucoma
Corneal irregular astigmatism (including corneal disease such as conical cornea)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Vision Research Laboratory
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city, Aichi
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Sakai |
Organization
Chukyo Eye Clinic
Division name
Orthoptist
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city, Aichi
TEL
052-883-1543
Homepage URL
sakai@chukyo-eyeclinic.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Chukyo Medical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chukyo Eye Clinic
Yuya Sato Eye Clinic
Hoshino Eye Clinic
Tomita Eye Clinic
Oka Eye Clinic
Nagoya Eye Clinic
Chayagasaka Eye Clinic
Nakamura Eye Clinic
Tomiyasu Eye Clinic
Okegawa Eye Clinic
Kobayashi Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo Medical Co., Ltd. REC
Address
12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya city, Aichi
Tel
052-884-7976
irb@chukyomedical.co.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
| 2018 | Year | 04 | Month | 10 | 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
0
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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036711
| 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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| Registered date | File name |
