Status:
COMPLETED
visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry
Lead Sponsor:
Wills Eye
Collaborating Sponsors:
Olleyes, Inc.
Conditions:
Glaucoma, Open-Angle
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Stan...
Detailed Description
Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucom...
Eligibility Criteria
Inclusion
- age 21 to 80 years
- Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP).
- mild glaucoma subjects with less than -6 mean deviation
- moderate glaucoma subjects with -6 to -12 mean deviation
Exclusion
- spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters
- Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts)
- Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses)
- SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma
- Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification)
- History of systemic condition known to affect visual function
- History of medication known to affect visual function
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03804684
Start Date
January 8 2019
End Date
October 20 2020
Last Update
June 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107