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Trial record 7 of 331 for:    Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | Macular Degeneration

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

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ClinicalTrials.gov Identifier: NCT02747368
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Vesa Aaltonen, 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).

Condition or disease Intervention/treatment Phase
Macular Degeneration Device: Ocusweep system Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Wet age related macular degeneration
Ocusweep system is compared to results of conventional devices.
Device: Ocusweep system
Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.




Primary Outcome Measures :
  1. Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field [ Time Frame: 2 years ]
  2. Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field [ Time Frame: 2 years ]
  3. Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score [ Time Frame: 2 years ]
  4. Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score [ Time Frame: 2 years ]
  5. 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 ]
  6. 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 ]
  7. Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores [ Time Frame: 4 years ]
  8. Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score [ Time Frame: 4 years ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Macular degeneration or other diagnosed or suspected macular disease

Exclusion Criteria:

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

Responsible Party: Vesa Aaltonen, Consultant in Ophthalmology, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02747368     History of Changes
Other Study ID Numbers: T220/2015
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vesa Aaltonen, Turku University Hospital:
Wet age-related macular degeneration
Age-related macular degeneration
Ocusweep
Driving health
Visual field
Contrast sensitivity

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases