The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD
ETAMD
1 other identifier
observational
11
1 country
1
Brief Summary
Data collection and observation of changes within AMD patients performing visual training on mobile devices
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2018
CompletedMarch 20, 2018
March 1, 2018
29 days
March 5, 2018
March 19, 2018
Conditions
Keywords
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)
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.
Eligibility Criteria
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
Central Study Contacts
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