Trial Outcomes & Findings for Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects (NCT NCT02526654)
NCT ID: NCT02526654
Last Updated: 2019-09-16
Results Overview
Pearson's correlation coefficient between Heidelberg Edge Perimeter (HEP) and Octopus Visual Field (OVF) Mean Deviation (MD) for glaucoma patients and controls to determine if HEP can detect glaucoma as well as OVF. The closer the values of both parameters for both machines, the better comparable the two machines are to each other in detecting glaucoma.
COMPLETED
NA
115 participants
Baseline visit, 1 hour
2019-09-16
Participant Flow
Patients were recruited from the Glaucoma Service at Wills Eye Hospital between December 2014 and June 2015. Healthy controls were recruited from staff, family and friends.
Before study tasks, Informed Consent was conducted and obtained according to the International Conference on Harmonization Good Clinical Practices (ICH GCP) guidelines with opportunity for all questions to be answered.
Participant milestones
| Measure |
Glaucoma Subjects
Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes.
|
Healthy Controls
Healthy subjects that do not have glaucoma and have no other eye diseases.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
36
|
|
Overall Study
COMPLETED
|
79
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects
Baseline characteristics by cohort
| Measure |
Glaucoma Subjects
n=79 Participants
Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes from the Glaucoma Service at Wills Eye Hospital in Philadelphia, Pennsylvania. They will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
|
Healthy Controls
n=36 Participants
Healthy control subjects that do not have glaucoma and are recruited for testing will perform visual field with Heidelberg Edge Perimeter and Octopus visual field from staff, family and friends of the Glaucoma Service at Wills Eye Hospital in Philadelphia, Pennsylvania. Optical Coherence Tomography will image the retinal nerve fiber layer.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=99 Participants
|
36 participants
n=107 Participants
|
115 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline visit, 1 hourPearson's correlation coefficient between Heidelberg Edge Perimeter (HEP) and Octopus Visual Field (OVF) Mean Deviation (MD) for glaucoma patients and controls to determine if HEP can detect glaucoma as well as OVF. The closer the values of both parameters for both machines, the better comparable the two machines are to each other in detecting glaucoma.
Outcome measures
| Measure |
Glaucoma Subjects
n=79 Participants
79 glaucoma subjects defined by characteristic glaucomatous disc damage and visual field changes
|
Healthy Controls
n=36 Participants
36 healthy control subjects with no glaucoma or other eye diseases.
|
|---|---|---|
|
Correlation Coefficient Between HEP and OVF Mean Deviation (MD)
|
-.86 Pearson's correlation coefficient
|
-.37 Pearson's correlation coefficient
|
SECONDARY outcome
Timeframe: Month 6 visit, 1 hourPopulation: not all eyes were included in this sub- analysis. inconclusive results were not included.
A subgroup of participants were randomly selected to return at 3 and 6 months for repeat testing. Not all eyes were included. Repeatability of optical coherence tomography (OCT) to consistently detect minimum rim width (MRW) global thickness will be assessed by Pearson's interclass correlation coefficients (ICC). A larger ICC indicates measurements have greater repeatability. Greater than 0.75 indicated excellent repeatability; 0.40 to 0.75 indicated fair to good, and less than 0.40 indicated poor reliability.
Outcome measures
| Measure |
Glaucoma Subjects
n=36 eyes
79 glaucoma subjects defined by characteristic glaucomatous disc damage and visual field changes
|
Healthy Controls
n=59 eyes
36 healthy control subjects with no glaucoma or other eye diseases.
|
|---|---|---|
|
Repeatability of Optical Coherence Tomography (OCT) Parameters
|
.99 Intraclass correlation coefficients
Interval 0.99 to 1.0
|
.99 Intraclass correlation coefficients
Interval 0.99 to 1.0
|
SECONDARY outcome
Timeframe: Baseline visit, 1 hourPopulation: Not all eyes (automated reports) met inclusion criteria. Healthy control eye were was not included in this portion of the study. Only glaucoma subgroup received clinical interpretations by 3 glaucoma specialists.
Heidelberg Edge Perimeter (HEP) Visual Field (VF) and spectral domain optical coherence tomography (SD OCT) printouts from only the glaucoma subgroup were assessed. Retinal Nerve Fiber Layer (RNFL) and Minimum Rim Width (MRW) from SD OCT and HEP VF automated reports were compared to the clinical interpretations by 3 glaucoma specialists.
Outcome measures
| Measure |
Glaucoma Subjects
n=53 eyes
79 glaucoma subjects defined by characteristic glaucomatous disc damage and visual field changes
|
Healthy Controls
36 healthy control subjects with no glaucoma or other eye diseases.
|
|---|---|---|
|
Correlations Between Structure-function Automated Report and Clinical Impression
|
0.62 Kappa
Interval 0.54 to 0.7
|
—
|
Adverse Events
Glaucoma Subjects
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. L. Jay Katz
Wills Eye Hospital, Glaucoma Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place