UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042823 |
|---|---|
| Receipt number | R000048890 |
| Scientific Title | Clinical evaluation of new toric intraocular lenses |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2022/12/25 09:07:32 |
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Basic information
Public title
Clinical evaluation of new toric intraocular lenses
Acronym
Clinical evaluation of new toric intraocular lenses
Scientific Title
Clinical evaluation of new toric intraocular lenses
Scientific Title:Acronym
Clinical evaluation of new toric intraocular lenses
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the surgical outcomes of improved version of toric intraocular lenses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
axis misalignment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cataract surgery using improved version of toric intraocular lenses
Interventions/Control_2
cataract surgery using old version of toric intraocular lenses
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cataract with astigmatism
Key exclusion criteria
diseases except for cataract
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | Oshika |
| Last name | Oshika |
Organization
University of Tsukuba
Division name
Ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
0298533148
oshika@eye.ac
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
University of Tsukuba
Division name
Ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
0298533148
Homepage URL
oshika@eye.ac
Sponsor or person
Institute
Kaiya Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Kaiya Eye Clinic
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
Kaiya Eye Clinic
Address
20-40 Sukenobucho, Nakaku, Hamamatsu, Shizuoka
Tel
053-476-3388
oshika@gmail.com
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
| 2020 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
10.3928/1081597X-20220715-02
Number of participants that the trial has enrolled
165
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
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2020 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048890
