Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects

Study Overview
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Brief Summary
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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.

Detailed Description
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Each participant undergo the following tests: 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). Octopus Visual Field (OVF) Analyzer using G-top strategy recording mean deviation (MD) and pattern standard deviation (PSD). Heidelberg Edge Perimeter (HEP) standard automated perimetry (SAP) using advanced staircase thresholding algorithm (ASTA). 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.

Official Title
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Validation and Reproducibility of the Heidelberg Edge Perimeter in the Detection of Visual Field Defects in Glaucomatous Patients

Conditions
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Glaucoma

Intervention / Treatment
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* Diagnostic Test: Heidelberg Edge Perimeter
* Diagnostic Test: Octopus Visual Field
* Diagnostic Test: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaucoma Subjects<br>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. | Diagnostic Test: Heidelberg Edge Perimeter<br>* HEP measures peripheral vision<br>* Other names: HEP;Diagnostic Test: Octopus Visual Field<br>* OVF measures peripheral vision<br>* Other names: OVF;Diagnostic Test: Optical Coherence Tomography<br>* OCT measures retinal nerve fiber layer thickness<br>* Other names: OCT;|
| Experimental: Healthy Controls<br>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. | Diagnostic Test: Heidelberg Edge Perimeter<br>* HEP measures peripheral vision<br>* Other names: HEP;Diagnostic Test: Octopus Visual Field<br>* OVF measures peripheral vision<br>* Other names: OVF;Diagnostic Test: Optical Coherence Tomography<br>* OCT measures retinal nerve fiber layer thickness<br>* Other names: OCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |