UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030529 |
|---|---|
| Receipt number | R000034852 |
| Scientific Title | Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2021/01/06 11:30:59 |
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Basic information
Public title
Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens
Acronym
Clinical utility of extended depth of focus intraocular lens
Scientific Title
Clinical utility of extended depth of focus intraocular lens to expand applying multifocal intraocular lens
Scientific Title:Acronym
Clinical utility of extended depth of focus intraocular lens
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical utility of extended depth of focus intraocular lens for eyes with irregular corneal astigmatism and eyes after refractive surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
contrast sensitivity
Key secondary outcomes
conventional visual acuity, functional visual acuity, binocular visual function
refraction, high order aberration, light scattering
QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patient with extended depth of focus intraocular lens (ZXR00V)
Interventions/Control_2
Patient with monofocal intraocular lens (ZCB00V)
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
Cataract patient with irregular corneal astigmatism or after refractive surgery
Key exclusion criteria
anisometropia, strabismus, dry eye, severe glaucoma, macular disease, optic nerve disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Hasegawa |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine,
Zip code
3058575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL
029-853-3148
ytamura-tuk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hasegawa |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine,
Zip code
3058575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL
029-853-3148
Homepage URL
ytamura-tuk@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
Amakubo 2-1-1 Tsukuba Ibaraki Japan
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.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 | 12 | Month | 25 | Day |
Related information
URL releasing protocol
https://tsukuba-eye.jp
Publication of results
Unpublished
Result
URL related to results and publications
https://tsukuba-eye.jp
Number of participants that the trial has enrolled
4
Results
There was no difference in postoperative contrast sensitivity between the symphony group and the monodical lens group.
Results date posted
| 2021 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with cataract surgery for eyes with corneal astigmatism that is more than twice the standard deviation (2SD) or with a history of refractive surgery
Participant flow
The principal investigator will explain the content of this study and the characteristics of each intraocular lens to the target patients, and the patient will decide which intraocular lens to use.
Adverse events
No
Outcome measures
contrast sensitivity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | 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 | 12 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034852
