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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02747368
• Other study ID #: T220/2015
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 8, 2016
• Last updated: April 25, 2017
• Start date: April 2016
• Est. completion date: April 2021

Study information

• Verified date: April 2017
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Macular degeneration or other diagnosed or suspected macular disease

Exclusion Criteria:

• Pregnancy

• Mental disorder

• Dementia and Alzheimers disease

• Prisoners

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field		2 years
Primary	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field		2 years
Primary	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score		2 years
Primary	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score		2 years
Primary	Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing		4 years
Primary	Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing		4 years
Primary	Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores		4 years
Primary	Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score		4 years
Primary	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		2 years
Primary	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		2 years
Primary	Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores		2 years
Primary	Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score		2 years