iCam Clinical Validation Study

Completed

• Conditions: Eye Disease

• Registration Number: NCT01600261
• Lead Sponsor: Optovue

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of clinically useful images	Day 1

Trial Locations

Locations (2)

Livermore Optometry Group; 🇺🇸 Livermore, California, United States

Buena Vista Eye Care; 🇺🇸 San Jose, California, United States