MedPath

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

Not Applicable
Conditions
Macula disease,Glaucoma
Registration Number
JPRN-UMIN000023317
Lead Sponsor
Topcon Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
400
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath