NCT02747368

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

5 years

First QC Date

April 8, 2016

Last Update Submit

April 25, 2017

Conditions

Macular Degeneration

Keywords

Wet age-related macular degenerationAge-related macular degenerationOcusweepDriving healthVisual fieldContrast sensitivity

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (1)

Wet age related macular degeneration

OTHER

Ocusweep system is compared to results of conventional devices.

Device: Ocusweep system

Interventions

Ocusweep systemDEVICE

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

Wet age related macular degeneration

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Macular degeneration or other diagnosed or suspected macular disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Ophthalmology

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 21, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share