UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052765 |
|---|---|
| Receipt number | R000055790 |
| Scientific Title | ICL implantation for age 46 and over |
| Date of disclosure of the study information | 2023/11/12 |
| Last modified on | 2024/05/12 10:26:58 |
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Basic information
Public title
Evaluation of posterior phakic intraocular lens implantation in cases of 46 and over years age
Acronym
ICL implantation for age 46 and over
Scientific Title
ICL implantation for age 46 and over
Scientific Title:Acronym
ICL implantation for age 46 and over
Region
| Japan |
Condition
Condition
refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of safety and effectiveness of posterior phakic intraocular lens implantation in cases with age 46 and over
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Uncorrected visual acuity, Best corrected visual acuity, postoperative refractive error
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
| Maneuver |
Interventions/Control_1
none
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
| 46 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Males and females aged 46 years or older with no eye disease other than refractive error who wish to undergo surgical treatment for myopia and myopic astigmatism
Key exclusion criteria
cases with eye disease other than refractive error
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ouchi |
Organization
Masayuki Ouchi Eye Clinic
Division name
Ophthalmology
Zip code
6018449
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto, Japan
TEL
0756625660
mouchi@skyblue.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ouchi |
Organization
Masayuki Ouchi Eye Clinic
Division name
Ophthalmology
Zip code
601-8449
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto, Japan
TEL
0756625660
Homepage URL
mouchi@skyblue.ocn.ne.jp
Sponsor or person
Institute
Masayuki Ouchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Masayuki Ouchi 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
Masayuki Ouchi Eye clinic
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto, Japan
Tel
0756625660
mouchi@skyblue.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
| 2023 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
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
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2023 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055790
