UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021159 |
|---|---|
| Receipt number | R000024381 |
| Scientific Title | Software Performance Validation Pre-Study on Glaucoma Patients |
| Date of disclosure of the study information | 2016/02/23 |
| Last modified on | 2022/08/30 10:34:38 |
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Basic information
Public title
Software Performance Validation Pre-Study on Glaucoma Patients
Acronym
Triton Validation Pre-Study
Scientific Title
Software Performance Validation Pre-Study on Glaucoma Patients
Scientific Title:Acronym
Triton Validation Pre-Study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Evaluate Repeatability of the Triton OCT compared to legally marketed device in glaucoma patients
2.Evaluate the measurement agreement between Triton and legally marketed device in glaucoma patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Repeatability in measurement of Retinal structures, for example Retinal nerve fiber layer thickness, Optic disc size and so on
Key secondary outcomes
Agreement that was determined by calculating the correlation between two devices
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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 30 years of age or older
3.Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
4.Subjects presenting at the site with glaucoma
5.BCVA 0.7 or better in the study eye
6.HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as Anderson and Patella criteria
7.MD should be better than -12.0 dB
8.IOP should be under control and less than 21 mmHg on the day of imaging
Key exclusion criteria
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 myopia including presence of tilted-disc syndrome or optic disc tilt (axial length > 27 mm*, posterior staphyloma, ridge at temporal side of the disc, parapapillary intrachoroidal cavitation, localized and/or diffuse chorio-retinal atrophy (detected by clinical exam or fundus-photograph)
5.Previous ocular surgery or laser treatment
6.History of leukemia, dementia or multiple sclerosis
7.Subjects with hypertension: Systolic blood pressure > 150 mmHg and diastolic pressure > 95 mmHg (medication OK)
8.Subjects with hypotension: Systolic blood pressure < 100 mmHg for age < 60 years old and systolic blood pressure < 110 mmHg with age 60 and above.
9.Narrow angle with Shaffer grade 2 or less
10.Pseudophakic or aphakic
Target sample size
60
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 | Akihiko |
| Middle name | |
| Last name | Sekine |
Organization
Topcon Corporation
Division name
Administration Department, Research & Development Division
Zip code
174-8580
Address
75-1,Hasunuma-cho, Itabashi-ku, Tokyo Japan
TEL
03-3558-2512
Homepage URL
asekine@topcon.com
Sponsor or person
Institute
Topcon Corporation
Institute
Department
Personal name
Funding Source
Organization
Tocpon 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
Kanto Central Hoapital Medical Ethics Committee
Address
6-25-1, Kamiyoga, 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
たじみ岩瀬眼科（岐阜県）、東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 23 | 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
61
Results
This result is planning to be published with the results of UMIN000024047
Results date posted
| 2019 | Year | 08 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
UMIN000024047 that will be published together decided to collect more about 130 participants for improving statistical reliability.
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
| 2015 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
A cross-sectional study
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024381
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