UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043643 |
|---|---|
| Receipt number | R000049834 |
| Scientific Title | Pre and postoperative all distance visual function after combined cataract and vitrectomy surgery |
| Date of disclosure of the study information | 2021/03/17 |
| Last modified on | 2023/11/09 12:21:05 |
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Basic information
Public title
Pre and postoperative all distance visual function after combined cataract and vitrectomy surgery
Acronym
Pre and postoperative all distance visual function after combined cataract and vitrectomy surgery
Scientific Title
Pre and postoperative all distance visual function after combined cataract and vitrectomy surgery
Scientific Title:Acronym
Pre and postoperative all distance visual function after combined cataract and vitrectomy surgery
Region
| Japan |
Condition
Condition
Vitreoretinal disorders and cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate pre and postoperative all distance visual acuity and contrast sensitivity after combined cataract and vitrectomy surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All distance 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
Eyes that have undergone combined vitrectomy and cataract surgery
Key exclusion criteria
Eyes with diseases that reduce visual function other than cataract and vitreoretinal diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiki |
| Middle name | |
| Last name | Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine,
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
fumiki-o@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hasegawa |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine,
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
Homepage URL
ytamura-tuk@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Santen
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
Tsukuba Clinical Research & Development Organization
Address
2-1-1 Amakubo Tsukuba, Ibaraki, Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.ac.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
| 2021 | Year | 03 | Month | 17 | 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
89
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
| 2019 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examination (preoperative, 1, 3, 6 months after surgery)
all distance visual acuity, all distance contrast sensitivity, functional visual acuity, light scattering, retinal sensitivity, vision-related quality of vision, wavefront aberration, corneal topography, retinal structure, intraocular lens, visibility of retina through vitrectomy
Management information
Registered date
| 2021 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049834
| Research Plan | |
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| 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 |
