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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043643
Receipt No. 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 2021/09/16

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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
Email 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
Email ytamura-tuk@umin.ac.jp

Sponsor
Institute Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department

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
Email 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
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
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
2022 Year 11 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
2021 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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