Study Comparing the P200TE and the P200TxE



Status:Recruiting
Conditions:Healthy Studies, Ocular
Therapuetic Areas:Ophthalmology, Other
Healthy:No
Age Range:22 - Any
Updated:3/14/2019
Start Date:February 15, 2019
End Date:March 8, 2019

Use our guide to learn which trials are right for you!

Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE

The study evaluates the image quality between two OCT devices and also collects usability
feedback.

The objective of this study is to collect OCT scans to compare the qualitative B scan images
produced by the P200TxE to the P200TE device on a variety of subjects with ocular disease and
no ocular disease. Usability feedback from operator and clinician will be collected.

Inclusion Criteria - Normal Group:

- Male or female subjects 22 years of age or older who have full legal capacity to
volunteer on the date the informed consent is signed;

- Subjects who can follow the instructions by the clinical staff at the clinical site;

- Subjects who agree to participate in the study;

- Subjects with normal eyes (without pathology) in both eyes on the date of the study
visit as confirmed by the investigator;

Exclusion Criteria - Normal Group:

- Subjects unable to tolerate ophthalmic imaging;

- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;

- Subjects with any current ocular pathology other than cataract as determined by
self-report and/or investigator assessment at the study visit;

- Subjects with history of dementia or multiple sclerosis.

Inclusion Criteria - Glaucoma Group:

- Male or female subjects 22 years of age or older who have full legal capacity to
volunteer on the date the informed consent is signed;

- Subjects who can follow the instructions by the clinical staff at the clinical site,

- Subjects who agree to participate in the study;

- Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the
investigator;

Exclusion Criteria - Glaucoma Group:

- Subjects unable to tolerate ophthalmic imaging;

- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;

- Subjects with any current ocular pathology except glaucoma, as determined by
self-report and/or investigator assessment on the day of the study visit.

- Subjects with history of dementia or multiple sclerosis.

- Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA)
visual field (24-2 or 30-2, white on white) measured on the day of the study visit or
within the previous six (6) months from the study visit, defined as fixation losses >
20% or false positives > 33%, or false negatives > 33%;

Inclusion Criteria - Retinal Disease Group:

- Male or female subjects 22 years of age or older who have full legal capacity to
volunteer on the date the informed consent is signed;

- Subjects who can follow the instructions by the clinical staff at the clinical site,

- Subjects who agree to participate in the study;

- Subjects diagnosed with retinal pathology such as: Macular Degeneration, Diabetic
Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema,
or other retinal disease as confirmed by the investigator.

Exclusion Criteria - Retina Disease Group:

- Subjects unable to tolerate ophthalmic imaging;

- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;

- Subjects with any current ocular pathology except retina pathology, as determined by
self-report and/or investigator assessment on the day of the study visit;

- Subjects with history of dementia or multiple sclerosis.
We found this trial at
2
sites
Poway, California 92064
Principal Investigator: Paul E Tornambe, MD
Phone: 858-451-1911
?
mi
from
Poway, CA
Click here to add this to my saved trials
La Jolla, California 92037
Principal Investigator: Paul E Tornambe, MD
Phone: 858-451-1911
?
mi
from
La Jolla, CA
Click here to add this to my saved trials