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 | 2025/03/24 10:19:03 |
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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
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
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
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. Several papers are in preparation or have been submitted.
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
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026896
