UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035631 |
|---|---|
| Receipt number | R000037962 |
| Scientific Title | Data analysis on cataract surgery using toric intraocular lenses |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2023/07/29 17:12:54 |
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Basic information
Public title
Data analysis on cataract surgery using toric intraocular lenses
Acronym
Data analysis on cataract surgery using toric intraocular lenses
Scientific Title
Data analysis on cataract surgery using toric intraocular lenses
Scientific Title:Acronym
Data analysis on cataract surgery using toric intraocular lenses
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Data analysis on cataract surgery using toric intraocular lenses
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
misalignment of toric intraocular lens, uncorrected visual acuity, corrected visual acuity, reflection, aberration, parameters of anterior part of the eye, post-operative halo, glare, starburst, patient satisfaction, frequency of eyeglass use
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who had cataract surgery and agreed to participate in the study by written informed consent
Key exclusion criteria
Patients who had cataract surgery but did not agree to participate in the study by written informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Tanabe |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
671-1227
Address
Himeji City aboshi waku 68-1
TEL
0792-98-8555
tennsyoudragon@icloud.com
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Tanabe |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
671-1227
Address
Himeji City aboshi waku 68-1
TEL
0792-98-8555
Homepage URL
tennsyoudragon@icloud.com
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Saneikai Tsukazaki Hospital
Address
Himeji City aboshi waku 68-1
Tel
0792-98-8555
tennsyoudragon@icloud.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
| 2019 | Year | 01 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data analysis on cataract surgery using toric intraocular lenses
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037962
| 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 |
