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

Not Applicable
Conditions
Macular Degeneration
Interventions
Device: Ocusweep system
Registration Number
NCT02747368
Lead Sponsor
Turku University Hospital
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
600
Inclusion Criteria
  • Macular degeneration or other diagnosed or suspected macular disease
Exclusion Criteria
  • Pregnancy
  • Mental disorder
  • Dementia and Alzheimers disease
  • Prisoners

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Wet age related macular degenerationOcusweep systemOcusweep system is compared to results of conventional devices.
Primary Outcome Measures
NameTimeMethod
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing4 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 testing2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores4 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 testing2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score2 years
Secondary Outcome Measures
NameTimeMethod
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