N/A
N=72
visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry
Glaucoma, Open-Angle
Bottom Line
View on ClinicalTrials.gov: NCT03804684 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Mean Retinal Sensitivity From Two Machines — 29.9; 24.8; 28.7; 22.9 decibels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Automatic Perimetry Humphrey Field Analyzer (Diagnostic_test); visuALL Field Analyzer (Diagnostic_test)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Retinal Sensitivity From Two Machines |
29.9; 24.8; 28.7; 22.9; 30.3; 24.8 | — |
| PRIMARY Global Correlation (Agreement Between Two Machines in the Overall Visual Field) |
0.5; 0.8 | — |
| SECONDARY Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field) |
0.3; 0.8 | — |
| SECONDARY Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field |
0.4; 0.6 | — |
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 Standard Automatic Perimetry (SAP).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03804684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.