Trial Outcomes & Findings for Comparison of Visual Field Assessments Between Three Perimeters (NCT NCT06539715)
NCT ID: NCT06539715
Last Updated: 2026-04-30
Results Overview
The total time to complete automated perimetry in both eyes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
54 participants
Primary outcome timeframe
Visit 1 (Day 0)
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
First TEMPO, Then VisuALL, Then Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
First TEMPO, Then Humphrey Field Analyzer, Then VisuALL
Visual field assessment: Automated perimetry
|
First VisuALL, Then TEMPO, Then Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
First VisuALL, Then Humphrey Field Analyzer, Then TEMPO
Visual field assessment: Automated perimetry
|
First Humphrey Field Analyzer, Then TEMPO, Then VisuALL
Visual field assessment: Automated perimetry
|
First Humphrey Field Analyzer, Then VisuALL, Then TEMPO
Visual field assessment: Automated perimetry
|
|---|---|---|---|---|---|---|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
First Intervention
COMPLETED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Second Intervention
COMPLETED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Third Intervention
COMPLETED
|
9
|
9
|
9
|
9
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=54 Participants
All participants received testing with all 3 devices.
|
|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 9.2 • n=54 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Day 0)The total time to complete automated perimetry in both eyes.
Outcome measures
| Measure |
TEMPO
n=54 Participants
Visual field assessment with the TEMPO
Visual field assessment: Automated perimetry
|
Humphrey Field Analyzer
n=54 Participants
Visual field assessment with the Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
VisuALL
n=54 Participants
Visual field assessment with the VisuALL
Visual field assessment: Automated perimetry
|
|---|---|---|---|
|
Total Acquisition Time (Both Eyes)
|
4.44 minutes
Standard Deviation 0.88
|
7.34 minutes
Standard Deviation 2.27
|
7.71 minutes
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Visit 1 (Day 0)visual field mean deviation (unit = decibels)
Outcome measures
| Measure |
TEMPO
n=54 Participants
Visual field assessment with the TEMPO
Visual field assessment: Automated perimetry
|
Humphrey Field Analyzer
n=54 Participants
Visual field assessment with the Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
VisuALL
n=54 Participants
Visual field assessment with the VisuALL
Visual field assessment: Automated perimetry
|
|---|---|---|---|
|
Mean Deviation (MD)
|
-3.16 dB
Standard Deviation 4.39
|
-3.28 dB
Standard Deviation 4.19
|
-4.22 dB
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Visit 1 (Day 0)visual field pattern standard deviation (unit = decibels) PSD is a measure of visual field irregularity.
Outcome measures
| Measure |
TEMPO
n=54 Participants
Visual field assessment with the TEMPO
Visual field assessment: Automated perimetry
|
Humphrey Field Analyzer
n=54 Participants
Visual field assessment with the Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
VisuALL
n=54 Participants
Visual field assessment with the VisuALL
Visual field assessment: Automated perimetry
|
|---|---|---|---|
|
Pattern Standard Deviation (PSD)
|
4.78 dB
Standard Deviation 3.82
|
4.22 dB
Standard Deviation 3.21
|
4.51 dB
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Visit 1 (Day 0)visual field foveal threshold (unit = decibels)
Outcome measures
| Measure |
TEMPO
n=54 Participants
Visual field assessment with the TEMPO
Visual field assessment: Automated perimetry
|
Humphrey Field Analyzer
n=54 Participants
Visual field assessment with the Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
VisuALL
n=54 Participants
Visual field assessment with the VisuALL
Visual field assessment: Automated perimetry
|
|---|---|---|---|
|
Foveal Threshold (FT)
|
31.40 dB
Standard Deviation 3.77
|
34.71 dB
Standard Deviation 3.63
|
27.61 dB
Standard Deviation 6.20
|
SECONDARY outcome
Timeframe: Visit 1 (Day 0)A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) that patients answered about the comfort, ease of use, and anxiety with each device. Strongly Agree was considered a better outcome for comfort and ease of use questions, and Strongly Disagree was considered a better outcome for anxiety questions.
Outcome measures
| Measure |
TEMPO
n=54 Participants
Visual field assessment with the TEMPO
Visual field assessment: Automated perimetry
|
Humphrey Field Analyzer
n=54 Participants
Visual field assessment with the Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
VisuALL
n=54 Participants
Visual field assessment with the VisuALL
Visual field assessment: Automated perimetry
|
|---|---|---|---|
|
Patient Questionnaire
Easy to Perform (%) "Agree" or "Strongly Agree"
|
53 Participants
|
28 Participants
|
45 Participants
|
|
Patient Questionnaire
Comfortable to Perform (%) "Agree" or "Strongly Agree"
|
48 Participants
|
16 Participants
|
40 Participants
|
|
Patient Questionnaire
Caused Anxiety (%) "Disagree" or "Strongly Disagree"
|
49 Participants
|
46 Participants
|
47 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day 0)Visual field Index goes from 100% = perfect to 0% = no vision
Outcome measures
| Measure |
TEMPO
n=54 Participants
Visual field assessment with the TEMPO
Visual field assessment: Automated perimetry
|
Humphrey Field Analyzer
n=49 Participants
Visual field assessment with the Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
VisuALL
n=54 Participants
Visual field assessment with the VisuALL
Visual field assessment: Automated perimetry
|
|---|---|---|---|
|
Visual Field Index (VFI)
|
91.60 percentage
Standard Deviation 12.49
|
91.27 percentage
Standard Deviation 11.64
|
92.30 percentage
Standard Deviation 12.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day 0)Total setup time was defined as the time from first instructions to each participant up to visual field acquisition start.
Outcome measures
| Measure |
TEMPO
n=54 Participants
Visual field assessment with the TEMPO
Visual field assessment: Automated perimetry
|
Humphrey Field Analyzer
n=54 Participants
Visual field assessment with the Humphrey Field Analyzer
Visual field assessment: Automated perimetry
|
VisuALL
n=54 Participants
Visual field assessment with the VisuALL
Visual field assessment: Automated perimetry
|
|---|---|---|---|
|
Setup Time
|
1.69 minutes
Standard Deviation 0.65
|
1.92 minutes
Standard Deviation 0.66
|
1.68 minutes
Standard Deviation 0.60
|
Adverse Events
TEMPO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Humphrey Field Analyzer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VisuALL
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