Glaucoma
Conditions
Brief summary
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.
Detailed description
Each participant undergo the following tests: 1. Standard ophthalmic examination (usual care): Best-corrected visual acuity, biomicroscopy (look at front of eye), intraocular pressure (IOP) using Goldman applanation tonometry, central corneal thickness measurement and fundoscopy (look at back of eye). 2. Octopus Visual Field (OVF) Analyzer using G-top strategy recording mean deviation (MD) and pattern standard deviation (PSD). 3. Heidelberg Edge Perimeter (HEP) standard automated perimetry (SAP) using advanced staircase thresholding algorithm (ASTA). 4. Spectralis optical coherence tomography (OCT) using glaucoma module premium edition (GMPE) software to measure minimum rim width (MRW) and retinal nerve fiber layer (RNFL) thickness in 6 sectors (superior nasal, superior temporal, inferior nasal, inferior temporal, nasal and temporal) in the retina. 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.
Interventions
DIAGNOSTIC_TESTHeidelberg Edge Perimeter
HEP measures peripheral vision
DIAGNOSTIC_TESTOctopus Visual Field
OVF measures peripheral vision
DIAGNOSTIC_TESTOptical Coherence Tomography
OCT measures retinal nerve fiber layer thickness
Sponsors
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 years. * Best corrected visual acuity of 20/40 or better in the tested eye. * Spherical refraction within ±5.0 D, and cylinder correction within ±3.0 D. * History of glaucoma, defined as: * Characteristic of glaucomatous disc damage: (local narrowing, notching, or absence of the neuroretinal rim in the absence of disc pallor elsewhere).
Exclusion criteria
* Any condition preventing adequate examination of the pupil or visual field testing (e.g. ptosis, dense corneal opacities or lens opacities); * Active infection of the anterior or posterior segments of the eye; * Any intraocular surgical or laser procedure within the previous 4 weeks; * Participants taking a medication known to affect visual field sensitivity, a coexisting intraocular disease affecting visual field, or a problem other than glaucoma affecting color vision will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Coefficient Between HEP and OVF Mean Deviation (MD) | Baseline visit, 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeatability of Optical Coherence Tomography (OCT) Parameters | Month 6 visit, 1 hour | 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. |
| Correlations Between Structure-function Automated Report and Clinical Impression | Baseline visit, 1 hour | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 79 |
| 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. | 36 |
| Total | 115 |
Baseline characteristics
| Characteristic | Glaucoma Subjects | Healthy Controls | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 56 Participants | 12 Participants | 68 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 24 Participants | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 15 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 55 Participants | 17 Participants | 72 Participants |
| Region of Enrollment United States | 79 participants | 36 participants | 115 participants |
| Sex: Female, Male Female | 46 Participants | 23 Participants | 69 Participants |
| Sex: Female, Male Male | 33 Participants | 13 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 36 |
| other Total, other adverse events | 0 / 79 | 0 / 36 |
| serious Total, serious adverse events | 0 / 79 | 0 / 36 |
Outcome results
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.
Time frame: Baseline visit, 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glaucoma Subjects | Correlation Coefficient Between HEP and OVF Mean Deviation (MD) | -.86 Pearson's correlation coefficient |
| Healthy Controls | Correlation Coefficient Between HEP and OVF Mean Deviation (MD) | -.37 Pearson's correlation coefficient |
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.
Time frame: Baseline visit, 1 hour
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glaucoma Subjects | Correlations Between Structure-function Automated Report and Clinical Impression | 0.62 Kappa |
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.
Time frame: Month 6 visit, 1 hour
Population: not all eyes were included in this sub- analysis. inconclusive results were not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glaucoma Subjects | Repeatability of Optical Coherence Tomography (OCT) Parameters | .99 Intraclass correlation coefficients |
| Healthy Controls | Repeatability of Optical Coherence Tomography (OCT) Parameters | .99 Intraclass correlation coefficients |