OCT Agreement and Crossed Precision Study
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 11/8/2014 |
| Start Date: | January 2014 |
| End Date: | June 2014 |
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.
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
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