Clinical trial NCT02747368: Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
Official title: Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Degeneration
Keywords: Wet age-related macular degeneration
Age-related macular degeneration
Ocusweep
Driving health
Visual field
Contrast sensitivity
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Macular degeneration or other diagnosed or suspected macular disease

Exclusion Criteria:

* Pregnancy
* Mental disorder
* Dementia and Alzheimers disease
* Prisoners

Primary outcomes:
measure: Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field
timeFrame: 2 years
measure: Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field
timeFrame: 2 years
measure: Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score
timeFrame: 2 years
measure: Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score
timeFrame: 2 years
measure: Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing
timeFrame: 4 years
measure: Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing
timeFrame: 4 years
measure: Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores
timeFrame: 4 years
measure: Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score
timeFrame: 4 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores
timeFrame: 2 years
measure: Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
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