Clinical Validation Study of RTVue Features

Completed

• Conditions: Healthy; Glaucoma

• Registration Number: NCT01370850
• Lead Sponsor: Optovue

Brief Summary

To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.

Detailed Description

Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-04-28
• Status Verified: 2011-06
• Study First Submitted QC: 2011-06-09
• Last Update Submitted: 2011-06-09
• Study First Posted: 2011-06-10
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
• Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
• Retina patients will have clinical exam results consistent with retina pathology.

Exclusion Criteria

• Normal subjects will be free of any ocular pathology.
• Glaucoma patients will be free of any ocular pathology except glaucoma.
• Retina patients will be free of any ocular pathology except any type of retina pathology.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retina measurement	at time of study visit (day 1)

Trial Locations

Locations (1)

Pacific Eye Specialists; 🇺🇸 Daly City, California, United States