UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048353 |
|---|---|
| Receipt number | R000055111 |
| Scientific Title | A study of visual function in 5-year postoperative patients with the multifocal posterior chamber lens LENTIS Comfort LS-313 MF15 |
| Date of disclosure of the study information | 2022/07/21 |
| Last modified on | 2023/04/10 17:36:38 |
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Basic information
Public title
A study of visual function in 5-year postoperative patients with the multifocal posterior chamber lens LENTIS Comfort
Acronym
A study of visual function in 5-year postoperative patients with the multifocal posterior chamber lens LENTIS Comfort
Scientific Title
A study of visual function in 5-year postoperative patients with the multifocal posterior chamber lens LENTIS Comfort LS-313 MF15
Scientific Title:Acronym
A study of visual function in 5-year postoperative patients with the multifocal posterior chamber lens LENTIS Comfort LS-313 MF15
Region
| Japan |
Condition
Condition
Patients after cataract surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate visual function in patients more than 5 years postoperatively with the multifocal posterior chamber lens LENTIS Comfort LS-313 MF15.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who participated in the clinical trial and were 5 years post-LC implantation
Key exclusion criteria
Patients with complications (eye or systemic) that affect postoperative visual function not related to LC implantation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Shii |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Yoshimura |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Sakura Clinic Research Ethics Committee
Address
5F,Inamura Building,1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,103-0025,Japan
Tel
03-6777-1490
c-irb_ug@neues.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
| 2022 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s40123-023-00703-2
Number of participants that the trial has enrolled
20
Results
Refer to published paper
Results date posted
| 2023 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 22 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is retrospective clinical study using existing hospital medical records.
The target number of eyes is indicated in "Target sample size ".
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055111
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
