iCam Clinical Validation Study

Optovue

Status: Completed

Conditions: Eye Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01600261

200-47425

Details and patient eligibility

About

Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.

Full description

Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Able and willing to complete the required examination

Exclusion criteria

• Spherical Equivalent outside -12 diopter to +15 diopter
• Without lens
• Inability to fixate

Trial design

131 participants in 1 patient group

eye exam