UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030508
Receipt number 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 18:06:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



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

Value
https://center6.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