UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040874 |
|---|---|
| Receipt number | R000046667 |
| Scientific Title | Recording ERG after vitrectomy in epiretinal membrane patients |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2024/06/29 09:12:07 |
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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
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
k-kato@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046667
