How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?
| Registry | NCT03804684 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 72 (Actual) |
| Sponsor | Wills Eye (Other); collaborators: Olleyes, Inc. |
| Conditions | Glaucoma, Open-Angle |
| Interventions | Standard Automatic Perimetry Humphrey Field Analyzer, visuALL Field Analyzer (Diagnostic test) |
| Dates | start 2019-01-08, primary completion 2020-10-20, completion 2020-10-20, first posted 2019-01-15, last updated 2022-06-29 |
| Locations | 1 site in United States |
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All trials for Glaucoma, Open-Angle All trials of Standard Automatic Perimetry Humphrey Field Analyzer All trials of visuALL Field Analyzer
To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).
Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.
Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.
The main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities. Other objectives of this study include the development of an initial reference database and comparison of the measured parameters with HFA.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy Controls | Experimental | Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL Field Analyzer | Healthy subjects between 21 and 80 years of age with no eye diseases (normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal and reliable standard automatic perimetry, and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. |
| Mild and Moderate Glaucoma | Experimental | Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL Field Analyzer | Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have a reliable standard automatic perimetry with no more than -6 mean deviation (Mild) and between -6 mean and -12 mean deviation (Moderate). Spherical refraction will be less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. |
Sex: All, ages: 21 Years to 80 Years, accepts healthy volunteers
Inclusion Criteria: * age 21 to 80 years * Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP). * mild glaucoma subjects with less than -6 mean deviation * moderate glaucoma subjects with -6 to -12 mean deviation Exclusion Criteria: * spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters * Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts) * Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses) * SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma * Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification) * History of systemic condition known to affect visual function * History of medication known to affect visual function
| Milestone | Healthy Controls | Glaucoma Group |
|---|---|---|
| Started | 28 | 44 |
| Completed | 25 | 26 |
| Not completed | 3 | 18 |
Time frame: 3 hours
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Healthy Controls | 0/28 (0.0%) | 0/28 (0.0%) | 0/28 (0.0%) |
| Glaucoma Group | 0/44 (0.0%) | 0/44 (0.0%) | 0/44 (0.0%) |
Limitations and caveats: Disadvantages of VisuALL are similar to standard automated perimetry. They rely on patient cooperation and concentration during visual field examination. In addition, the system does not include follow-up analysis. The head-mounted device may not be preferred by subjects with claustrophobic tendencies.
| Facility | City | Country | Status |
|---|---|---|---|
| Wills Eye Hospital | Philadelphia, Pennsylvania | United States |