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Software Performance Validation Pre-Study on Glaucoma Patients

Software Performance Validation Pre-Study on Glaucoma Patients - Triton Validation Pre-Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000021159
Enrollment
60
Registered
2016-02-23
Start date
2016-02-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Interventions

None listed

Sponsors

Topcon Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Repeatability in measurement of Retinal structures, for example Retinal nerve fiber layer thickness, Optic disc size and so on

Secondary

MeasureTime frame
Agreement that was determined by calculating the correlation between two devices

Countries

Japan,Asia(except Japan)

Contacts

Public ContactAkihiko Sekine

Topcon Corporation Administration Department, Research & Development Division

asekine@topcon.com03-3558-2512

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026