iCam Clinical Validation Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01600261

Enrollment

131

Registered

2012-05-17

Start date

2012-04-30

Completion date

2012-06-30

Last updated

2012-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Disease

Keywords

without eye disease

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
proportion of clinically useful images	Day 1

Countries

United States

Outcome results