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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02747368

Enrollment

600

Registered

2016-04-21

Start date

2016-04-30

Completion date

2021-04-30

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

Wet age-related macular degeneration, Age-related macular degeneration, Ocusweep, Driving health, Visual field, Contrast sensitivity

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).

Interventions

DEVICEOcusweep system

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Macular degeneration or other diagnosed or suspected macular disease

Exclusion criteria

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026