UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056617 |
|---|---|
| Receipt number | R000064707 |
| Scientific Title | clinical results of light adjustable lens |
| Date of disclosure of the study information | 2025/01/03 |
| Last modified on | 2025/07/05 09:29:01 |
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Basic information
Public title
clinical results of light adjustable lens
Acronym
clinical results of light adjustable lens
Scientific Title
clinical results of light adjustable lens
Scientific Title:Acronym
clinical results of light adjustable lens
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
light adjustable lens is new in Japan and clinical results are analysed and compare them with other lenses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity
Key secondary outcomes
refraction
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with cataract surgery
Key exclusion criteria
severe complications
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | masahiko |
| Middle name | |
| Last name | ayaki |
Organization
eye clinic
Division name
eye
Zip code
1080075
Address
2-16-3 konan, minatoku
TEL
09022118355
mayaki@olive.ocn.ne.jp
Public contact
Name of contact person
| 1st name | masahiko |
| Middle name | |
| Last name | ayaki |
Organization
grand central tower tokyo eye clinic
Division name
eye
Zip code
1080075
Address
2-16-3 konan, minatoku
TEL
09022118355
Homepage URL
mayaki@olive.ocn.ne.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
masahiko ayaki
Funding Source
Organization
personal fund
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
IRB of chukyo eye clinic
Address
sanbonmatsu, atsuta, nagoya
Tel
09022118355
mayaki@olive.ocn.ne.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
| 2025 | Year | 01 | Month | 03 | 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
Main results already published
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 05 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 05 | Day |
Date analysis concluded
| 2035 | Year | 12 | Month | 31 | Day |
Other
Other related information
visual acuity and refraction will be recorded and analysed before and after surgery
Management information
Registered date
| 2025 | Year | 01 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064707
