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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000023317
Enrollment
400
Registered
2016-07-25
Start date
2007-05-20
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

Macula disease,Glaucoma

Interventions

None listed

Sponsors

Topcon Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Contacts

Public ContactAkihiko Sekine

Topcon Corporation Eye-care Business unit

a.sekine@topcon.co.jp03-3966-3141

Outcome results

None listed

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