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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
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 8, 2016
    Last Updated
    April 25, 2017
    Sponsor
    Turku University Hospital
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    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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