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The purpose of this study is to compare standard automated perimetry (SAP) using the Heidelberg Edge Perimeter (HEP) to the Octopus Visual Field (OVF) analyzer and determine test-retest reliability of both parameters in detecting glaucomatous visual field losses. This study will also investigate novel imaging parameters of the optic nerve head and new automated structure-function reports.
Each participant undergo the following tests:
Order of HEP SAP III and OVF, and order of the eye tested (right vs. left) if both eyes of patients meet inclusion criteria will be randomized. Patients with glaucoma will be randomly chosen and asked to return in 3 to 6 months for repeat HEP and OVF testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma Subjects | Experimental | Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes. 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 | Experimental | Subjects that do not have glaucoma and are recruited for testing will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heidelberg Edge Perimeter | Diagnostic Test | HEP measures peripheral vision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficient Between HEP and OVF Mean Deviation (MD) | 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. | Baseline visit, 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of Optical Coherence Tomography (OCT) Parameters | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie J Katz, MD | Wills Eye Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29396688 | Result | Cui QN, Fudemberg SJ, Resende AF, Vu TA, Zhou C, Rahmatnejad K, Hark LA, Myers JS, Katz LJ, Waisbourd M. Validation of the structure-function correlation report from the heidelberg edge perimeter and spectral-domain optical coherence tomography. Int Ophthalmol. 2019 Mar;39(3):533-540. doi: 10.1007/s10792-018-0836-z. Epub 2018 Feb 2. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glaucoma Subjects | Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes. |
| FG001 | Healthy Controls | Healthy subjects that do not have glaucoma and have no other eye diseases. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glaucoma Subjects | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Coefficient Between HEP and OVF Mean Deviation (MD) | 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. | Posted | Number | Pearson's correlation coefficient | Baseline visit, 1 hour |
|
eye examination, 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glaucoma Subjects | Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes. |
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Small sample size and varied severity of disease in the glaucoma group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. L. Jay Katz | Wills Eye Hospital, Glaucoma Research Center | 215-928-3123 | ljkatz@willseye.org |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Octopus Visual Field | Diagnostic Test | OVF measures peripheral vision |
|
|
| Optical Coherence Tomography | Diagnostic Test | OCT measures retinal nerve fiber layer thickness |
|
|
| Month 6 visit, 1 hour |
| Correlations Between Structure-function Automated Report and Clinical Impression | 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. | Baseline visit, 1 hour |
| BG001 |
| Healthy Controls |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Repeatability of Optical Coherence Tomography (OCT) Parameters | 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. | not all eyes were included in this sub- analysis. inconclusive results were not included. | Posted | Number | 95% Confidence Interval | Intraclass correlation coefficients | Month 6 visit, 1 hour | eyes | eyes |
|
|
|
| Secondary | Correlations Between Structure-function Automated Report and Clinical Impression | 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. | 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. | Posted | Number | 95% Confidence Interval | Kappa | Baseline visit, 1 hour | eyes | eyes |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Healthy Controls | Healthy control subjects that do not have glaucoma or other eye diseases. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |