Normal Eyes
Conditions
Brief summary
The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.
Detailed description
The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE
Interventions
DEVICEP200TE
The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.
Sponsors
Optos, PLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects 22 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 (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed. 4. BCVA (best corrected visual acuity) 20/40 or better(each eye) 5. Subject is able to comply with the study procedures
Exclusion criteria
1. Subjects unable to tolerate ophthalmic imaging 2. Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study 3. Subject with ocular media not sufficiently clear toobtain acceptable OCT images 4. .History of leukemia, dementia or multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Thickness | 1 year | The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria. |
| GCC Thickness | 1 year | The GCC Thickness |
| RNFL Thickness | 1 year | The RNFL thickness |
| Optic Nerve Head | 1 year | The ONH size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 year | Number of any adverse events associated with the clinical study to ensure device safety. |
Countries
United States
Outcome results
None listed