The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD (ETAMD)

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

Study Overview

• Status: Unknown
• Conditions: AMD
• Intervention / Treatment: Device: Medical-Eye-Trainer (MET)

Detailed Description

In the presented study a training-therapy in patients with dry AMD war evaluated. The main focus was on remote visibility and thus better handling of daily activities.

Therapy with high-contrast administration is used for amblyopia in childhood. Furthermore, simulation therapy is used in hemianopsia in the adult age, in which case the lesion is usually not located in the eye.

This stimulating therapy for children and adult patients led to the hypothesis that this treatment could also improve AMD's situation. The entire visual procedure also shows the possibility of change even in adult patients.

The presented study investigates if regular training with a device that provides a moving grating-stimulus, the "Medical Eye Trainer" (MET), can improve the subjective perception of visual performance during typical activities of daily living. The aims of the study were not to show improvement of reading vision nor to show changes in the retinal structure.

• Study Type: Observational
• Enrollment (Anticipated): 11

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Ried Im Innkreis, Upper Austria, Austria, 4910
      • Recruiting
      • Krankenhaus der Barmherzigen Schwestern Ried
      • Contact: Robert Hörantner, MD; Phone Number: 07752 602; Email: robert.hoerantner@bhs.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Intervention Group; Repetitive Training with Medical-Eye-Trainer (MET)

Device: Medical-Eye-Trainer (MET); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	6 meter - Decimal	Baseline - 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Satisfaction	better - no Change - worse	Baseline - 3 months

Collaborators and Investigators

• Sponsor: University of Applied Sciences Upper Austria
• Collaborators: Krankenhaus der Barmherzigen Schwestern Ried

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): May 15, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Training; AMD; Mobile Device
• Other Study ID Numbers: Uasua

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No