UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024047
Receipt number R000026896
Scientific Title Myopic and Glaucomatous optic neuropathy changes using swept source OCT
Date of disclosure of the study information 2016/09/23
Last modified on 2024/03/26 14:20:09

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Basic information

Public title

Myopic and Glaucomatous optic neuropathy changes using swept source OCT

Acronym

Myopia study

Scientific Title

Myopic and Glaucomatous optic neuropathy changes using swept source OCT

Scientific Title:Acronym

Myopia study

Region

Japan Asia(except Japan) North America


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1.Compare various retinal structures of normals, myopic normal, non-myopic glaucoma, and myopic glaucoma eyes in order to determine the structural changes associated with each group and be able to differentiate myopic changes compared to glaucomatous changes.
2.Retinal structures investigated in this study will be:
a.Thicknesses of various layers in posterior segment of the eye.
b.Optic disc parameters etc.
3.Correlations will be made between each of the structures investigated and patient characteristics including age, refractive error, axial length, IOP, central corneal thickness, and visual field MD and PSD values.

Basic objectives2

Others

Basic objectives -Others

Providing the reference limits of normal myopic persons.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Thickness differences between groups. Statistical significance will be defined at the 0.05 level. A multivariate ANOVA.
Correlations between the thickness values and patient characteristics including: age, refractive error, axial length, IOP, central corneal thickness, and visual field MD and PSD values.

Key secondary outcomes



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

30 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Normal persons:
1.Refractive error a)between +1 diopter sphere to -2 diopter sphere, b)between -2 diopter sphere to -5 diopter sphere, c)worse than -5 diopter sphere, all category are up to -2 diopter cylinder
2.Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3.Both eyes must be free from eye disease and possibility of disease

Glaucoma patients:
1.Refractive error a)between +1 diopter sphere to -2 diopter sphere, b)between -2 diopter sphere to -5 diopter sphere, c)worse than -5 diopter sphere, all category are up to -2 diopter cylinder
2.Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3.Subjects presenting at the site with glaucoma
4.HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as Anderson and Patella criteria. This criteria includes: Abnormal GHT, PSD < 5%, or 3 points <=5% with one point <=1% in the upper or lower hemifield in the pattern deviation plot.
5.MD should be better than -12.0 dB
6.IOP should be under control and less than 21 mmHg on the day of imaging

Key exclusion criteria

Normal persons:
1.Family history of glaucoma
2.Subjects unable to tolerate ophthalmic imaging
3.Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4.HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 1%, unless due to an enlarged blind spot.
5.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 > 15%
6.Presence of any ocular pathology or suggestive pathologic observation
7.Previous cataract surgery or refractive surgery, Pseudophakic or aphakic
8.Narrow angle with Shaffer grade 2 or less
9.History of diabetes, leukemia, dementia or multiple sclerosis (disease that produces defect of retinal nerve)
10.History of whole body dosing of steroid or/and anticancer agent
11.Subjects with hypertension/hypotension

Glaucoma patients:
1.Subjects unable to tolerate ophthalmic imaging
2.Subject with ocular media not sufficiently clear to obtain acceptable OCT images
3.HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 20% or false positives > 15%
4.Presence of any ocular pathology other than glaucoma, or suggestive pathologic observation
5.Previous ocular surgery or laser treatment
6.History of diabetes, leukemia, dementia or multiple sclerosis (disease that produces defect of retinal nerve)
7.History of whole body dosing of steroid or/and anticancer agent
8.Subjects with hypertension/hypotension
9.Narrow angle with Shaffer grade 2 or less
10.Pseudophakic or aphakic

Target sample size

220


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Araie

Organization

Kanto Central Hospital of the Mutual Aid Association of Public School Teachers

Division name

Ophthalmology

Zip code

158-8531

Address

6-25-1, Kamiyouga, Setagaya-ku, Tokyo Japan

TEL

03-3429-1171

Email

araie-tky@umin.net


Public contact

Name of contact person

1st name Tsutomu
Middle name
Last name Kikawa

Organization

Topcon Corporation

Division name

R&D Depertment, R&D Division

Zip code

174-8580

Address

75-1, Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan

TEL

03-3558-2512

Homepage URL


Email

tkikawa@topcon.com


Sponsor or person

Institute

Topcon Corporation

Institute

Department

Personal name



Funding Source

Organization

Topcon Corporation

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

Medical ethics committee of Kanto Central Hospital

Address

6-25-1, Kamiyouga, Setagaya-ku, Tokyo Japan

Tel

03-3429-1171

Email

m_kondo@kanto-ctr-hsp.com


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

関東中央病院(東京都)、たじみ岩瀬眼科(岐阜県)、東邦大学大橋病院(東京都)、東北大学病院(宮城県)、大阪大学病院(大阪府)、東京医科歯科大学病院(東京都)、香港中文大学病院(香港)、ソウル大学病院(韓国)、カリフォルニア大学サンディエゴ校(米国)、東京大学病院(東京都)、金沢大学病院(石川県)


Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 23 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

373

Results

It will be analyzing after add about 130 participants.
Number of analyzed participants : 328
Reporting about partial results at academic conference started.

Examples of secondary analysis results:
https://doi.org/10.1016/j.ajo.2023.01.003
https://doi.org/10.1016/j.ajo.2024.02.017

Results date posted

2020 Year 02 Month 25 Day

Results Delayed

Delay expected

Results Delay Reason

Additional data collection has finished and data analysis is carrying out.

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

No longer recruiting

Date of protocol fixation

2016 Year 07 Month 14 Day

Date of IRB

2016 Year 08 Month 08 Day

Anticipated trial start date

2017 Year 03 Month 18 Day

Last follow-up date

2019 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 09 Month 30 Day


Other

Other related information

The cross-sectional study


Management information

Registered date

2016 Year 09 Month 14 Day

Last modified on

2024 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026896


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name