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

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.

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