UMIN-CTR Clinical Trial

Public title

Collection of OCT measurement data on normal healthy eyes by 3D OCT-1000, and development of analysis software

Acronym

Topcon OCT Normative database study

Scientific Title

Collection of OCT measurement data on normal healthy eyes by 3D OCT-1000, and development of analysis software

Scientific Title:Acronym

Topcon OCT Normative database study

Region

Japan

Condition

Macula disease,Glaucoma

Classification by specialty

Ophthalmology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to collect OCT measurement data on Japanese normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1000 and to develop the screening software by analyzing data.

Basic objectives2

Others

Basic objectives -Others

It provides the standard data of Japanese normal eyes to us together with ophthalmologic data that was collected simultaneously. It is used as comparison data at the time of the development of the diagnostic method for glaucoma or retina diseases.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Retina thickness
(RNFLT, ILM-RPE thickness, Ganglion cell complex thickness etc.)

Key secondary outcomes

Correlation between age distribution of retina thickness and age distributions of refraction, corneal curvature and axial length.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Subjects 20 years of age or older on the date of informed consent
2.Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

Key exclusion criteria

1.HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives> 33%, or false negatives> 33%
2.Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings:
a)On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
b)Glaucoma hemi-field test "outside normal limits."
3.BCVA is worse than 20/25
4.SE > +5D or SE < -6D
5.Narrow angle with Shaffer grade 2 or less
6.Subject is not able to be measured axial legth
7.History of followed ocular pathology
a)IOP > 22mmHg
b)Disc hemorrhage
c)Diabetic retinopathy
d)Previous cataract surgery or refractive surgery
e)Corneal pathology
8.Congenital anomaly of retina
9.History of diabetes, leukemia, dementia or multiple sclerosis (disease that produces defect of retinal nerve)
10.Subject with ocular media not sufficiently clear to obtain acceptable OCT images
11.Concomitant use of hydroxychloroquine and chloroquine

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Araie

Organization

The University of Tokyo

Division name

Department of Ophthalmology

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo Japan

TEL

03-3815-5411

Email

araie-tky@umin.net

Name of contact person

1st name
Middle name
Last name	Akihiko Sekine

Organization

Topcon Corporation

Division name

Eye-care Business unit

Zip code

Address

75-1, Hasunuma-cho, Itabashi-ku, Tokyo Japan

TEL

03-3966-3141

Homepage URL

Email

a.sekine@topcon.co.jp

Institute

Topcon Corporation

Institute

Department

Personal name

Organization

Topcon Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学病院（東京都）、多治見市民病院（岐阜県）、京都大学病院（京都府）、大阪大学病院（大阪府）、金沢大学病院（石川県）、新潟大学病院（新潟県）、群馬大学病院（群馬県）

Date of disclosure of the study information

2016

Year

07

Month

25

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

05

Month

06

Day

Date of IRB

Anticipated trial start date

2007

Year

05

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2008

Year

09

Month

30

Day

Date analysis concluded

Other related information

A cross-sectional study.

Registered date

2016

Year

07

Month

24

Day

Last modified on

2016

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026848