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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040874
Receipt No. R000046667
Scientific Title Recording ERG after vitrectomy in epiretinal membrane patients
Date of disclosure of the study information 2020/12/01
Last modified on 2020/12/23

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Basic information
Public title Recording ERG after vitrectomy in epiretinal membrane patients
Acronym ERM-ERG
Scientific Title Recording ERG after vitrectomy in epiretinal membrane patients
Scientific Title:Acronym ERM-ERG
Region
Japan

Condition
Condition Epiretinal membrane
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recoding ERG after vitrectomy in the patients with epiretinal membrane.
Basic objectives2 Others
Basic objectives -Others Analyze the perioperative changes of implicit times and amplitudes of flicker ERG.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recoding flicker ERG perioperative period of vitrectomy; before surgery, 1day, 1 week, 1 month, 3 month after the surgery.
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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have epiretinal membrane
Key exclusion criteria Diabetic retinopathy, pseudoexfoliation syndrome, retinal vein occlusion, uveitis, excessive myopia, glaucoma, retinal degeneration
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kumiko
Middle name
Last name Kato
Organization Mie University School of Medicine
Division name Department of Ophthalmology
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie, Japan
TEL 059-231-5027
Email k-kato@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Kumiko
Middle name
Last name Kato
Organization Mie University School of Medicine
Division name Department of Ophthalmology
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie, Japan
TEL 059-231-5027
Homepage URL
Email k-kato@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization Encouragement of study donation
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 Clinical Research and Development Center of Mie University Hospital
Address 2-174 Edobashi, Tsu, Mie, Japan
Tel 059-231-5246
Email kk-sien@mo.medic.mie-u.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
2020 Year 12 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
2020 Year 06 Month 23 Day
Date of IRB
2020 Year 10 Month 16 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are planning to record flicker ERGs during the perioperative period of vitrectomy in the patients who diagnosed as epiretinal membrane.

Management information
Registered date
2020 Year 06 Month 23 Day
Last modified on
2020 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046667

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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