OCT Agreement and Crossed Precision Study

Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02050880

Enrollment

119

Registered

2014-01-31

Start date

2014-01-31

Completion date

2014-06-30

Last updated

2014-09-29

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

Conditions

Corneal Disease, Glaucoma, Retinal Disease

Keywords

Normal Eyes, Eye; Disorder with Glaucoma, Eye; Disorder with Retinal Disease, Eye; Disorder Corneal Disease incl kerato-refractive group

Brief summary

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

NORMAL EYES * Subjects who do not have pathology in both eyes Inclusion Criteria: GLAUCOMA * Subjects who have a glaucoma diagnosis Inclusion Criteria: RETINAL * Subjects who have a retinal diagnosis including but not limited to: 1. Diabetic macular edema 2. Dry age related macular degeneration 3. Wet age related macular degeneration 4. Cystoid macular edema 5. Epiretinal membrane 6. Macular hole Inclusion Criteria: CORNEAL * Subjects who has one of these diagnosis: 1. Post status LASIK surgery 2. Keratoconus 3. Other corneal dystrophies or degenerations.

Exclusion criteria

ALL EYES * Subjects who have any of the following conditions 1. Diabetes mellitus (DM) and/or diabetic retinopathy 2. Uncontrolled Hypertension (HT) 3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision 4. Cardiac, hepatic, renal and hematologic diseases 5. A current condition requiring systemic administration of steroid 6. A history of, or currently receiving, anticancer therapy 7. Epileptic seizures which are optically induced 8. Dementia * Subjects who have other life threatening and debilitating systemic diseases Note: Additional criteria may apply

Design outcomes

Primary

Measure	Time frame	Description
Retinal thickness	Approximately four hours	Time frame is the maximum duration of hospital stay
Optic Disc Analysis	Approximately four hours	Time frame is the maximum duration of hospital stay
Corneal Thickness	Approximately four hours	Time frame is the maximum duration of hospital stay

Countries

United States

Outcome results