Trial Outcomes & Findings for Human Optokinetic Contrast Device (HOCD) to Measure Visual Function and Identify Patients With and Without Glaucoma (NCT NCT02014597)
NCT ID: NCT02014597
Last Updated: 2023-05-11
Results Overview
The HOCD willl be used to estimate the logCS of both eyes in both dark (scotopic) and light (photopic) conditions.
TERMINATED
NA
23 participants
Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment and 1 month later - not started (early Termination).
2023-05-11
Participant Flow
Normal subjects were recruited by word of mouth (medical clinic staff, employees, friends, relatives); Glaucoma subjects were recruited from a glaucoma specific clinic.
Unit of analysis: Eyes
Participant milestones
| Measure |
Normal
Normal subjects without glaucoma
|
Glaucoma
Subjects with glaucoma
|
|---|---|---|
|
Overall Study
STARTED
|
12 24
|
11 22
|
|
Overall Study
COMPLETED
|
10 20
|
10 20
|
|
Overall Study
NOT COMPLETED
|
2 4
|
1 2
|
Reasons for withdrawal
| Measure |
Normal
Normal subjects without glaucoma
|
Glaucoma
Subjects with glaucoma
|
|---|---|---|
|
Overall Study
Unable to record log contrast sensitivity
|
2
|
1
|
Baseline Characteristics
Human Optokinetic Contrast Device (HOCD) to Measure Visual Function and Identify Patients With and Without Glaucoma
Baseline characteristics by cohort
| Measure |
Normal
n=12 Participants
Normal subjects without glaucoma
|
Glaucoma
n=11 Participants
Subjects with glaucoma
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Best Corrected Vision = 20/40 or better
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment and 1 month later - not started (early Termination).Population: Scotopic and photopic logCS for both eyes (right and left)
The HOCD willl be used to estimate the logCS of both eyes in both dark (scotopic) and light (photopic) conditions.
Outcome measures
| Measure |
Normal
n=20 Eyes
Normal subjects without glaucoma
|
Glaucoma
n=20 Eyes
Subjects with glaucoma
|
|---|---|---|
|
Estimated Contrast Sensitivity in Log Units (logCS)
Scotopic - right eyes
|
1.26 logCS
Interval 1.19 to 1.58
|
1.50 logCS
Interval 1.43 to 1.6
|
|
Estimated Contrast Sensitivity in Log Units (logCS)
Scotopic - left eyes
|
1.45 logCS
Interval 1.32 to 1.64
|
1.70 logCS
Interval 1.35 to 1.91
|
|
Estimated Contrast Sensitivity in Log Units (logCS)
Photopic - right eyes
|
0.264 logCS
Interval -0.428 to 1.57
|
-0.188 logCS
Interval -0.44 to 0.0417
|
|
Estimated Contrast Sensitivity in Log Units (logCS)
Photopic - left eyes
|
1.06 logCS
Interval -0.0663 to 1.62
|
-0.0933 logCS
Interval -0.502 to 0.857
|
SECONDARY outcome
Timeframe: Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment and 1 month later - not started (early Termination).Population: Scotopic and photopic logCS (right and left eyes pooled together)
Measure differences in logCS between subjects with and without glaucoma.
Outcome measures
| Measure |
Normal
n=20 Eyes
Normal subjects without glaucoma
|
Glaucoma
n=20 Eyes
Subjects with glaucoma
|
|---|---|---|
|
Compare Log Contrast Sensitivity in Subjects With and Without Glaucoma
Scotopic - all eyes
|
1.42 logCS
Interval 1.22 to 1.58
|
1.52 logCS
Interval 1.36 to 1.81
|
|
Compare Log Contrast Sensitivity in Subjects With and Without Glaucoma
Photopic - all eyes
|
0.65 logCS
Interval -0.322 to 1.59
|
-0.188 logCS
Interval -0.462 to 0.536
|
SECONDARY outcome
Timeframe: Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment - not started (early Termination).Population: Only subjects with glaucoma had automated perimetry for comparison in Study 1. Eyes were pooled for analysis.
Measure contrast sensitivity with the HOCD (logCS) and then compare to automated perimetry results (Decibels). For subjects with glaucoma this will be performed as part of both Study 1 and Study 2. For normal control subjects, this will only be performed as part of Study 2.
Outcome measures
| Measure |
Normal
Normal subjects without glaucoma
|
Glaucoma
n=20 Eyes
Subjects with glaucoma
|
|---|---|---|
|
Compare Log Contrast Sensitivity Measured With the HOCD to White on White Sensitivity Via Automated Perimetry
MD
|
—
|
-2.82 Decibels
Standard Deviation 3.27
|
|
Compare Log Contrast Sensitivity Measured With the HOCD to White on White Sensitivity Via Automated Perimetry
PSD
|
—
|
4.34 Decibels
Standard Deviation 3.41
|
SECONDARY outcome
Timeframe: Study 2: Measured 1 month after the day of enrollment - not started (early Termination).Population: Study 2 never performed due to early Termination
Compare contrast sensitivity measured with the HOCD (logCS) to contrast sensitivity testing via Pelli Robson Contrast Sensitivity Chart testing. Study 2 only.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured 1 month after the day of enrollment - not started (early Termination).Population: Only the subjects for whom testing was completed are described.
Subjects will be asked to relate their experiences with the test to determine how well it is tolerated. Subjects will be asked to report their agreement with five statements. This is reported on a custom scale: 1 = Do Not Agree; 2 = Partially Agree; 3 = Mostly Agree; 4 = Fully Agree. Higher scores represent more complete agreement with the statement.
Outcome measures
| Measure |
Normal
n=10 Participants
Normal subjects without glaucoma
|
Glaucoma
n=10 Participants
Subjects with glaucoma
|
|---|---|---|
|
Tolerance of Testing as Measured Via Questionnaire
I understood the test instructions.
|
3.9 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Tolerance of Testing as Measured Via Questionnaire
I was physically comfortable during the test.
|
3.7 score on a scale
Interval 3.0 to 4.0
|
3.6 score on a scale
Interval 2.0 to 4.0
|
|
Tolerance of Testing as Measured Via Questionnaire
The length of the test was appropriate.
|
2.8 score on a scale
Interval 1.0 to 4.0
|
3.6 score on a scale
Interval 2.0 to 4.0
|
|
Tolerance of Testing as Measured Via Questionnaire
I had problems with the time spent in the dark.
|
1.3 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Tolerance of Testing as Measured Via Questionnaire
I would recommend this test if likely to diagnose glaucoma sooner.
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
Adverse Events
Normal
Glaucoma
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