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

NCT ID: NCT02747368

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Wet age related macular degeneration

Ocusweep system is compared to results of conventional devices.

Group Type OTHER

Ocusweep system

Intervention Type DEVICE

Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.

Interventions

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Ocusweep system

Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Macular degeneration or other diagnosed or suspected macular disease

Exclusion Criteria

* Pregnancy
* Mental disorder
* Dementia and Alzheimers disease
* Prisoners
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Vesa Aaltonen

Consultant in Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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T220/2015

Identifier Type: -

Identifier Source: org_study_id

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