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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037993
Receipt No. R000043305
Scientific Title Recording electroretinogram of postoperative inflammation after cataract surgery with RETeval system
Date of disclosure of the study information 2020/04/01
Last modified on 2020/12/23

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Basic information
Public title Recording electroretinogram of postoperative inflammation after cataract surgery with RETeval system
Acronym Electroretinogram during perioperative cataract surgery
Scientific Title Recording electroretinogram of postoperative inflammation after cataract surgery with RETeval system
Scientific Title:Acronym CAT-ERG
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We recorded flicker ERGs from patients who are going to take cataract surgery. ERGs will be recorded according to the schedule. We are going to examine if we can evaluate postoperative inflammation with ERGs recorded by RETeval system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in implicit times and amplitude of flicker ERGs.
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 are going to take cataract surgery at department of Ophthalmology of Mie University hospital.
Key exclusion criteria Diabetes mellitus, epiretinal membrane, pseudoexfoliation syndrome, retinal vein occlusion, uveitis, glaucoma, retinal degenerative disorder.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kumiko
Middle name
Last name Kato
Organization Mie University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code 514-8507
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-1111
Email ganka@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Kumiko
Middle name
Last name Kato
Organization Mie University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code 514-8507
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-1111
Homepage URL
Email ganka@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Encouragement of study donation (other than a company)
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 Research and Development Center of Mie University Hospital
Address 2-174, Edobashi, Tsu, Mie
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 04 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
2019 Year 05 Month 30 Day
Date of IRB
2019 Year 09 Month 30 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2022 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 going to examine the patients with flicker ERG, OCT, aqueous flare.

Management information
Registered date
2019 Year 09 Month 11 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=R000043305

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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