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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011321
Receipt No. R000013221
Scientific Title Usage of Gore-Tex sheet in surgeries for blepharoptosis, lid retraction, and orbital injury.
Date of disclosure of the study information 2013/07/31
Last modified on 2015/11/26

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Basic information
Public title Usage of Gore-Tex sheet in surgeries for blepharoptosis, lid retraction, and orbital injury.
Acronym Gore-Tex sheet in eyelid and orbital surgeries.
Scientific Title Usage of Gore-Tex sheet in surgeries for blepharoptosis, lid retraction, and orbital injury.
Scientific Title:Acronym Gore-Tex sheet in eyelid and orbital surgeries.
Region
Japan

Condition
Condition surgeries for blepharoptosis, lid retraction, and orbital injury.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of Gore-Tex sheet in surgeries for blepharoptosis, lid retraction, and orbital injury.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection of cases with re-operation for complication of Gore-Tex sheet.
Key secondary outcomes To evaluate safety and efficacy of Gore-tex sheet in orbital surgeries.

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
10 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Blepharoptosis surgery is indicated for cases with eyelid margin-pupil distance is less than 2 mm.
Eyelid retraction surgery is indicated for cases with eyelid margin is over above the corneal upper margin.
Orbital fracture surgery is indicated for cases with diplopia and orbital tissue herniation.
Key exclusion criteria 1) History of allergy for Gore-tex
2) Keloid diathesis
3) suspected orbital tumor
4) Multiple facial fracture
5) Others decided as to contra- indication by the director.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Sugiyama
Organization Kanazawa University
Division name Department of Ophthalmology
Zip code
Address 13-1 Takara-machi, Kanazawa city, Ishikawa Pref.
TEL 076-265-2403
Email ksugi@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Takahira
Organization Kanazawa University
Division name Department of Ophthalmology
Zip code
Address 3-1 Takara-machi, Kanazawa city, Ishikawa Pref.
TEL 076-265-2403
Homepage URL
Email takahira@med.kanazawa-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Kanazawa University
Institute
Department

Funding Source
Organization Department of Ophthalmology, Kanazawa University
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
2013 Year 07 Month 31 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
2012 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation for ophthalmic findings

Management information
Registered date
2013 Year 07 Month 30 Day
Last modified on
2015 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013221

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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