UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009114 |
|---|---|
| Receipt number | R000010689 |
| Scientific Title | Examination of prognostic factor by OCT in patient with epiretinal membrane |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2012/10/15 16:14:03 |
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Basic information
Public title
Examination of prognostic factor by OCT in patient with epiretinal membrane
Acronym
Examination of prognostic factor by OCT in patient with epiretinal membrane
Scientific Title
Examination of prognostic factor by OCT in patient with epiretinal membrane
Scientific Title:Acronym
Examination of prognostic factor by OCT in patient with epiretinal membrane
Region
| Japan |
Condition
Condition
epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prognostic factors for vitrectomy in patients with epiretinal
membrane (ERM) using spectral-domain optical coherence tomography (SD-OCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prognostic factors influencing postoperative BCVA.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with epiretinal membrane
Key exclusion criteria
eyes with secondary ERM caused by conditions such as diabetic retinopathy, venous
occlusion, retinal detachment, uveitis, trauma, or other ocular pathologies that could have
interfered with the functional results, especially patients with severe cataract of more than
grade 3 nuclear sclerosis and/or cortical opacity, were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | shiono akira |
Organization
st marianna university school of medicine
Division name
depertment of ophthalmology
Zip code
Address
sugao miyamae ward kawasaki city 2-16-1
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
st marianna university school of medicine
Division name
depertment of ophthalmology
Zip code
Address
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
department of ophthalmology
Institute
Department
Personal name
Funding Source
Organization
department of ophthalmology
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
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
| 2012 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ophthalmic evaluations included best-corrected visual acuity (BCVA) and OCT parameters
before and 1, 3, and 6 months after surgery
Management information
Registered date
| 2012 | Year | 10 | Month | 15 | Day |
Last modified on
| 2012 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010689
