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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007392
Receipt No. 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 2014/02/27

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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
Email 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
Email ttomomatsu@live.jp

Sponsor
Institute Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2012 Year 02 Month 18 Day
Date of IRB
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
2014 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008589

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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