Clinical Validation Study for iVue

Optovue

Status: Completed

Conditions: Normal and Ocular Pathology

Study type: Observational

Funder types: Industry

Identifiers

NCT01242553

iVue 100-2009

Details and patient eligibility

About

To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Normal: Normal results from clinical exam and free of ocular pathology.
• Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
• Cornea: Clinical exam results consistent with cornea pathology.
• Retina: Clinical exam results consistent with retina pathology

Trial design

48 participants in 4 patient groups

Normal

Description:

Normal results from clinical exam and free of ocular pathology.

Retina

Description:

Clinical exam results consistent with retina pathology

Glaucoma

Description:

Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.

Cornea

Description:

Clinical exam results consistent with cornea pathology.