iCam Clinical Validation Study

Eye Disease Clinical Trial

Official title:

iCam Clinical Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600261
• Other study ID #: 200-47425
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: June 27, 2012
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Optovue
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Eye Disease
• Eye Diseases

Locations

Country	Name	City	State
United States	Livermore Optometry Group	Livermore	California
United States	Buena Vista Eye Care	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Optovue

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of clinically useful images		Day 1	No