Clinical Validation Study of RTVue Features

Optovue

Status: Completed

Conditions: Healthy; Glaucoma

Study type: Observational

Funder types: Industry

Identifiers

NCT01370850

RTVue Validation Study

Details and patient eligibility

About

To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.

Full description

Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
• Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
• Retina patients will have clinical exam results consistent with retina pathology.

Exclusion criteria

• Normal subjects will be free of any ocular pathology.
• Glaucoma patients will be free of any ocular pathology except glaucoma.
• Retina patients will be free of any ocular pathology except any type of retina pathology.

Trial design

53 participants in 3 patient groups

Normal

Description:

Normal results from the clinical exam and free of ocular pathology.

Glaucoma

Description:

Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.

Retina

Description:

Clinical exam results consistent with retina pathology.