NCT03461393

Brief Summary

Data collection and observation of changes within AMD patients performing visual training on mobile devices

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

29 days

First QC Date

March 5, 2018

Last Update Submit

March 19, 2018

Conditions

Keywords

AMDMobile DeviceTraining

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    6 meter - Decimal

    Baseline - 3 months

Secondary Outcomes (1)

  • Subjective Satisfaction

    Baseline - 3 months

Study Arms (1)

Intervention Group

Repetitive Training with Medical-Eye-Trainer (MET)

Device: Medical-Eye-Trainer (MET)

Interventions

In order to provide a high contrast, dynamic visual stimulus to the patients, we developed an app that allowed the patients to regularly train with this stimulus. The app runs on Android (version 4.2 or later). The display of the screen is divided into 4 rows. In each row, a pattern of black and white squares is moving in one direction. The directions in subsequent rows are opposite to each other. Through the movement in the opposite direction a changing pattern is achieved in vertical and horizontal extension, the pattern alternates between continuous beams and a checkered pattern. The speed of the display on the monitor is 2 cm per second. In a comfortable viewing distance (ca. 40 cm), this leads to an angular velocity of approximately 3°/sec.

Intervention Group

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the study, 11 patients were included. In five of those, both eyes were affected by AMD; in the six other patients, only one eye was affected. The age of the patients was 72 ± 14.7 years (mean ± standard deviation, range 44 - 86 years). Eight eyes had received a lutein therapy for more than 2 years, according to the Age-Related Eye Diseases Study (AREDS) study. In two eyes an anti-VEGF (vascular endothelial growth factor ) therapy had been performed before (3.5 and 4 years ago, respecitvely); and in one eye a photodynamic therapy (PDT) had been performed 9 years ago. All eyes had been affected by dry AMD for 3.5 years or more. The visual acuity had been unchanged for at least a year in all patients. None of the patients reported any previous occurrence of epilepsy.

You may qualify if:

  • All eyes had been affected by dry AMD for 3.5 years or more

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krankenhaus der Barmherzigen Schwestern Ried

Ried im Innkreis, Upper Austria, 4910, Austria

RECRUITING

Central Study Contacts

Robert Hörantner, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.(FH) Dr.

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 12, 2018

Study Start

April 1, 2018

Primary Completion

April 30, 2018

Study Completion

May 15, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations