Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration

Study Overview
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Brief Summary
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The aim is to study the use of Ocusweep system especially in driving health evaluation and compare the results produced by Ocusweep system to those of conventional devices. The main focus is in patients suffering from wet age-related macular degeneration. The study aims to find out how frequently these patients do not meet the European Union health criteria of safe driving and how Ocusweep finds these patients from a population of patients being treated in a busy medical retina clinic. The tests of Ocusweep system are compared against conventional visual field tests, contrast sensitivity tests, visual acuity tests and tests showing anatomical changes related to wet age-related macular degeneration (optical coherence tomography, fundus photography and fluorescein or indocyanine green angiography).

Official Title
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Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration

Conditions
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Macular Degeneration

Intervention / Treatment
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* Device: Ocusweep system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Macular degeneration or other diagnosed or suspected macular disease Exclusion Criteria: Pregnancy Mental disorder Dementia and Alzheimers disease Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wet age related macular degeneration<br>Ocusweep system is compared to results of conventional devices. | Device: Ocusweep system<br>* Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field |  | 2 years | 
| Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field |  | 2 years | 
| Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score |  | 2 years | 
| Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score |  | 2 years | 
| Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing |  | 4 years | 
| Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing |  | 4 years | 
| Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores |  | 4 years | 
| Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score |  | 4 years | 
| Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by central visual field testing |  | 2 years | 
| Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by peripheral visual field testing |  | 2 years | 
| Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores |  | 2 years | 
| Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet age-related macular degeneration, Age-related macular degeneration, Ocusweep, Driving health, Visual field, Contrast sensitivity