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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035354
Receipt No. R000040249
Scientific Title Visual field changes after vitrectomy for macular diseases
Date of disclosure of the study information 2019/01/01
Last modified on 2018/12/24

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Basic information
Public title Visual field changes after vitrectomy for macular diseases
Acronym VF changes after vitrectomy
Scientific Title Visual field changes after vitrectomy for macular diseases
Scientific Title:Acronym VF changes after vitrectomy
Region
Japan

Condition
Condition macular hole, epiretinal membrane
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate visual field changes after vitrectomy for macular disease. Also, we evaluate factors related to postoperative visual field changes.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual field changes 3, 6, 12, and 24 months after vitrectomy.
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 (1) Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
(2) Eyes with epiretinal membrane or macular hole
Key exclusion criteria 1) History of disease which affect the visual field sensitivity except glaucoma, epiretinal membrane, and macular hole.
2) Patients with history of refractive surgery, vitreous surgery or retinal detachment surgery.
3)History of amblyopia (annisometropic amblyopia and refractive amblyopia)
4) Unable to perform visual field test.
5) Patients who were judged to be ineligible for this study.
Target sample size 150

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Sigiyama
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Ophthalmology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2000
Email ganjimu2@med.kanazawa-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomomi Higashide
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Ophthalmology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2000
Homepage URL
Email eyetomo@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 01 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
2011 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This prospective cohort study consists of patients with epiretinal membrane or macular hole who meet the inclusion criteria and undergo visual field tests before and after vitrectomy in the Kanazawa University Hospital after May 2011.

Management information
Registered date
2018 Year 12 Month 24 Day
Last modified on
2018 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040249

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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