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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030508
Receipt No. R000032637
Scientific Title Evaluation of anterior segment image analysis using Swept Source OCT
Date of disclosure of the study information 2017/12/22
Last modified on 2019/01/17

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Basic information
Public title Evaluation of anterior segment image analysis using Swept Source OCT
Acronym Evaluation of anterior segment analysis using SS OCT
Scientific Title Evaluation of anterior segment image analysis using Swept Source OCT
Scientific Title:Acronym Evaluation of anterior segment analysis using SS OCT
Region
Japan

Condition
Condition glaucoma, corneal dystrophy, leucoma, corneal degeneration, corneal irregular astigmatism, bullous keratopathy, keratoconus, lens disease, post corneal transplantation
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of anterior segment image analysis using Swept Source OCT PLEX elite 9000 (manufactured by Carl Zeiss Meditech), which attached unapproved anterior segment attachment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the number of taking anterior segment images by using Swept Source OCT and Cirrus 4000 HD-OCT for Anterior chamber depth, Angle opening degree, and Corneal thickness
Key secondary outcomes correlation with OCT image, visual acuity, intraocular pressure, and Fundus findings

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Analyzing images acquired using Swept Source OCT and Cirrus 4000 HD-OCT when the cases are enrolled and images acquired as needed during fifty two weeks from the enrollment of this study
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Those who are visiting or hospitalized at Ophthalmology Department of Shiga Medical University Hospital during this research period
2)Those who have an abnormality in the anterior ocular segment such as cornea, angle, iris
3)Those who can obtain agreement to research participation
Key exclusion criteria 1)Those who might induce epileptic seizures by light stimulation
2)Those who receive photodynamic therapy within forty eight hours
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamasa Mori
Organization Shiga University of Medical Science
Division name department of opthalmology
Zip code
Address Seta-Tsukinowacho, Otsu, Shiga, Japan
TEL 077-548-2276
Email mrtkms23@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Mori
Organization Shiga University of Medical Science
Division name department of opthalmology
Zip code
Address Seta-Tsukinowacho, Otsu, Shiga, Japan
TEL 077-548-2276
Homepage URL
Email mrtkms23@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Carl Zeiss Meditec, Inc.
Organization
Division
Category of Funding Organization Profit organization
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 滋賀医科大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 22 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
2017 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 23 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 21 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032637

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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