OCT Agreement and Crossed Precision Study

Nidek

Status

Completed

Conditions

Corneal Disease

Glaucoma

Retinal Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT02050880

RS-3000 series Protocol 1

Details and patient eligibility

About

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.

Enrollment

119 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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