Clinical Validation of New OCT System

Topcon DRI OCT-1 Optical Coherence Tomography System for the Acquisition of Retinal Thickness Measurements and Ocular Images of the Posterior Chamber: Agreement and Precision Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01809704

Enrollment

Registered

2013-03-13

Start date

2013-02-25

Completion date

2013-07-03

Last updated

2022-06-10

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

Conditions

Subjects Presenting With Normal or With Ocular Pathology

Brief summary

To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

for Normal Group 1. Subjects 18 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 3. Subjects presenting at the site with normal eyes (eyes without pathology) 4. IOP ≤ 21 mmHg bilaterally 5. BCVA 20/40 or better bilaterally 6. Both eyes must be free of eye disease

Exclusion criteria

for Normal Group 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 abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 1% 4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 33% or false positives \> 25%, or false negatives \> 25% 5. Presence of any ocular pathology except for cataract 6. Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning 7. Narrow angle 8. History of leukemia, dementia or multiple sclerosis 9. Concomitant use of hydroxychloroquine and chloroquine Inclusion Criteria for Glaucoma Group 1. Subjects 18 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 3. Subjects presenting at the site with glaucoma 4. BCVA 20/40 or better in the study eye 5. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 1% in the study eye

Design outcomes

Primary

Measure	Time frame
Retinal Thickness	Day 1

Countries

United States

Outcome results