UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028520 |
|---|---|
| Receipt number | R000032613 |
| Scientific Title | Investigation on cataract treatment result using multi-focal intraocular lens, AcrivaUDReviol Tri-ED and Tri-ED T 611 |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2021/03/12 11:41:19 |
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Basic information
Public title
Investigation on cataract treatment result using multi-focal intraocular lens, AcrivaUDReviol Tri-ED and Tri-ED T 611
Acronym
Investigation on postoperative result of multi-focal intraocular lens, AcrivaUDReviol Tri-ED
Scientific Title
Investigation on cataract treatment result using multi-focal intraocular lens, AcrivaUDReviol Tri-ED and Tri-ED T 611
Scientific Title:Acronym
Investigation on postoperative result of multi-focal intraocular lens, AcrivaUDReviol Tri-ED
Region
| Japan |
Condition
Condition
Age-related cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation on cataract treatment result using multi-focal intraocular lens, AcrivaUDReviol Tri-ED and Tri-ED T 611
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Visual test 1week, 1 month, 3 months, 6 months after the surgery (test distance: 5m, 70cm, 40cm), objective and subjective refractive value, questionnaire evaluation (presence of halo or glare), intraocular pressure, number of corneal endothelial cell.
-When Tri-ED T 611 is implanted astigmatic axis of the 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
Inserted one piece of intraocular lens per one eye, the observation
period is until six months after 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Applicant for multi-focal intraocular lens AcrivaUDReviol Tri-ED and Tri-ED T 611 among cataract surgery applicant.
Key exclusion criteria
Fundus disease
Glaucoma
Corneal irregular astigmatism (including corneal disease like 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
12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya, 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
12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya, 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
Self funding
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, 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
| 2017 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
20
Results
A relatively good intermediate and near vision were obtained.
Results date posted
| 2021 | Year | 03 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age was 60.9+-9.7
6 male eyes
14 female eyes
Average axial length was 26.23+-2.14mm
Preoperative average corneal power was 43.83+-1.44D
Average degree of cataract before surgery was 2.60+-0.86
Breakdown of Toric cases: +1.0D (5 eyes) and +1.5D (2 eyes)
Participant flow
20 cases with 20 eyes with the subject intraocular lens (IOL) implantation
Adverse events
none
Outcome measures
Value is average +- standard deviation
Uncorrected distance vision-0.09+-0.10
Corrected distance vision-0.17+-0.08
Uncorrected intermediate vision 0.08+-0.12
Distance corrected intermediate vision 0.05+-0.07
Uncorrected near vision 0.14+-0.11
Distance corrected near vision 0.10+-0.08
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 05 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032613
