UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007392 |
|---|---|
| Receipt number | R000008589 |
| Scientific Title | The morphologic differences in idiopathic epiretinal membranes and visual outcomes after vitreous surgery |
| Date of disclosure of the study information | 2012/02/29 |
| Last modified on | 2022/08/16 17:48:17 |
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Basic information
Public title
The morphologic differences in idiopathic epiretinal membranes and visual outcomes after vitreous surgery
Acronym
The morphology of idiopathic epiretinal membranes and visual outcomes
Scientific Title
The morphologic differences in idiopathic epiretinal membranes and visual outcomes after vitreous surgery
Scientific Title:Acronym
The morphology of idiopathic epiretinal membranes and visual outcomes
Region
| Japan |
Condition
Condition
idiopathic epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the visual outcomes after vitreous surgery and the morphology of idiopathic epiretinal membrane.
Basic objectives2
Others
Basic objectives -Others
Clinical avairability
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Best corrected visual acuity at 12 months after surgery.
Macular thickness at 12 months after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Flat shaped morphology in in epiretinal membranes before surgery.
Interventions/Control_2
Mountain shaped morphology in in epiretinal membranes before surgery.
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
| 35 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who was diagnosed with idiopathic epiretinal membrane and undergone vitreous surgery.
Key exclusion criteria
Cases of secondary epiretinal membrane, a history of ocular surgery and inflammation, the presence of other ocular diseases, and intraoperative complications such as posterior capsule rupture and severe iris damage. Cases with severe lens opacity (more than grade 4 for any type of cataract: cortical, nuclear or posterior subcapsular) by the LOCS (lens opacities classification system) III classification.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomomatsu |
Organization
University of Fukui, Faculty of medicine
Division name
Ophthalmology
Zip code
Address
23-3 Shimoaiduki Matsuoka Yoshida Fukui
TEL
0776-61-8403
ttomomatsu@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomomatsu |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL
0776-61-8403
Homepage URL
ttomomatsu@live.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
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
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 | 02 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 27 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008589
