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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010495
Receipt No. R000010452
Scientific Title Rigid gas-permeable contact lens assisted cataract surgery
Date of disclosure of the study information 2013/04/15
Last modified on 2015/10/29

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Basic information
Public title Rigid gas-permeable contact lens assisted cataract surgery
Acronym Rigid gas-permeable contact lens assisted cataract surgery
Scientific Title Rigid gas-permeable contact lens assisted cataract surgery
Scientific Title:Acronym Rigid gas-permeable contact lens assisted cataract surgery
Region
Japan

Condition
Condition cataract with corneal disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve visibility of anterior chamber in cataract surgery using hard contact lens on the cornea.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visibility of anterior chamber in cataract surgery
Key secondary outcomes visual acuity, intraocular pressure, corneal epithelium disorder (superficial punctate keratitis with fluorescein staining, corneal erosion)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 From Apr/2013 until Sep/2017 fifty cases of hard contact lens in cataract surgery
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria cataract with corneal disease in Osaka University Hospital
Key exclusion criteria under twenty years old
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Oie
Organization Osaka University Medical School
Division name Department of Ophthalmology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3456
Email yoie@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Oie
Organization Osaka University Medical School
Division name Department of Ophthalmology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3456
Homepage URL
Email yoie@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University Medical School
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 12 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 15 Day
Last modified on
2015 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010452

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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