Trial Outcomes & Findings for visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry (NCT NCT03804684)
NCT ID: NCT03804684
Last Updated: 2022-06-29
Results Overview
Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
three hours
Results posted on
2022-06-29
Participant Flow
Glaucoma patients with mild or moderate visual field loss and subjects with healthy vision were enrolled to form two groups for comparison of two methods of visual field testing. Subjects unable to perform testing or test reliability did not meet inclusion criteria in 3 of the Healthy Controls and 18 of the Glaucoma Group. Therefore, 21 participants were excluded from results.
Participant milestones
| Measure |
Healthy Controls
Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
Glaucoma Group
Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
44
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
18
|
Reasons for withdrawal
| Measure |
Healthy Controls
Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
Glaucoma Group
Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
|---|---|---|
|
Overall Study
Subjects unable to perform testing or test reliability did not meet inclusion criteria.
|
3
|
18
|
Baseline Characteristics
visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=50 Eyes
Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.
visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.
|
Glaucoma Group
n=52 Eyes
Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.
visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.
|
Total
n=102 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
44 participants
n=4 Participants
|
72 participants
n=27 Participants
|
|
Mild to Moderate Glaucoma
|
0 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Number of eyes analyzed
total eyes analyzed
|
50 number of eyes
n=93 Participants
|
52 number of eyes
n=4 Participants
|
102 number of eyes
n=27 Participants
|
|
Number of eyes analyzed
eyes with mild visual field defects
|
0 number of eyes
n=93 Participants
|
36 number of eyes
n=4 Participants
|
36 number of eyes
n=27 Participants
|
|
Number of eyes analyzed
eyes with moderate visual field defects
|
0 number of eyes
n=93 Participants
|
13 number of eyes
n=4 Participants
|
13 number of eyes
n=27 Participants
|
|
Number of eyes analyzed
eyes with severe visual field defects
|
0 number of eyes
n=93 Participants
|
3 number of eyes
n=4 Participants
|
3 number of eyes
n=27 Participants
|
PRIMARY outcome
Timeframe: three hoursMean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.
Outcome measures
| Measure |
Healthy Controls
n=50 Eyes
Healthy subjects between 21 and 80 years of age with no eye diseases. Fifty eyes with normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
Glaucoma Group
n=52 Eyes
Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Fifty-two eyes with reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
|---|---|---|
|
Mean Retinal Sensitivity From Two Machines
Global field from Humphrey Visual Field
|
29.9 decibels
Standard Deviation 1.4
|
24.8 decibels
Standard Deviation 3.9
|
|
Mean Retinal Sensitivity From Two Machines
Global field from VisuALL
|
28.7 decibels
Standard Deviation 1.3
|
22.9 decibels
Standard Deviation 4.9
|
|
Mean Retinal Sensitivity From Two Machines
Inferior nasal quadrant from Humphrey Visual Field
|
30.3 decibels
Standard Deviation 1.3
|
24.8 decibels
Standard Deviation 5.8
|
|
Mean Retinal Sensitivity From Two Machines
Inferior nasal quadrant from VisuALL
|
28.7 decibels
Standard Deviation 1.6
|
23.3 decibels
Standard Deviation 6.9
|
|
Mean Retinal Sensitivity From Two Machines
Superior hemifield from Humphrey Visual Field
|
29.5 decibels
Standard Deviation 1.5
|
23.7 decibels
Standard Deviation 5.0
|
|
Mean Retinal Sensitivity From Two Machines
Superior hemifield from VisuALL
|
28.6 decibels
Standard Deviation 1.6
|
21.8 decibels
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: three hoursPopulation: The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their visual field (overall).
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.
Outcome measures
| Measure |
Healthy Controls
n=50 Eyes
Healthy subjects between 21 and 80 years of age with no eye diseases. Fifty eyes with normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
Glaucoma Group
n=52 Eyes
Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Fifty-two eyes with reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
|---|---|---|
|
Global Correlation (Agreement Between Two Machines in the Overall Visual Field)
|
0.5 decibels
Interval 0.0 to 1.0
|
0.8 decibels
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: three hoursPopulation: The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their inferior nasal visual field).
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines.
Outcome measures
| Measure |
Healthy Controls
n=50 Eyes
Healthy subjects between 21 and 80 years of age with no eye diseases. Fifty eyes with normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
Glaucoma Group
n=52 Eyes
Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Fifty-two eyes with reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
|---|---|---|
|
Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)
|
0.3 decibels
Interval 0.0 to 1.0
|
0.8 decibels
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: three hoursPopulation: The mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across the superior hemifield portion of their visual field.
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines.
Outcome measures
| Measure |
Healthy Controls
n=50 Eyes
Healthy subjects between 21 and 80 years of age with no eye diseases. Fifty eyes with normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
Glaucoma Group
n=52 Eyes
Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Fifty-two eyes with reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
|
|---|---|---|
|
Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field
|
0.4 decibels
Interval 0.0 to 1.0
|
0.6 decibels
Interval 0.0 to 1.0
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucoma Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place