Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
Primary Purpose
Macular Degeneration
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ocusweep system
Sponsored by
About this trial
This is an interventional screening trial for Macular Degeneration focused on measuring Wet age-related macular degeneration, Age-related macular degeneration, Ocusweep, Driving health, Visual field, Contrast sensitivity
Eligibility Criteria
Inclusion Criteria:
- Macular degeneration or other diagnosed or suspected macular disease
Exclusion Criteria:
- Pregnancy
- Mental disorder
- Dementia and Alzheimers disease
- Prisoners
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Wet age related macular degeneration
Arm Description
Ocusweep system is compared to results of conventional devices.
Outcomes
Primary Outcome Measures
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score
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
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
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score
Secondary Outcome Measures
Full Information
NCT ID
NCT02747368
First Posted
April 8, 2016
Last Updated
April 25, 2017
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02747368
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Wet age-related macular degeneration, Age-related macular degeneration, Ocusweep, Driving health, Visual field, Contrast sensitivity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wet age related macular degeneration
Arm Type
Other
Arm Description
Ocusweep system is compared to results of conventional devices.
Intervention Type
Device
Intervention Name(s)
Ocusweep system
Intervention Description
Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.
Primary Outcome Measure Information:
Title
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field
Time Frame
2 years
Title
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field
Time Frame
2 years
Title
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score
Time Frame
2 years
Title
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score
Time Frame
2 years
Title
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing
Time Frame
4 years
Title
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing
Time Frame
4 years
Title
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores
Time Frame
4 years
Title
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score
Time Frame
4 years
Title
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
Time Frame
2 years
Title
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
Time Frame
2 years
Title
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores
Time Frame
2 years
Title
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Macular degeneration or other diagnosed or suspected macular disease
Exclusion Criteria:
Pregnancy
Mental disorder
Dementia and Alzheimers disease
Prisoners
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
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