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

Sponsor

University of Applied Sciences Upper Austria (Other)

Overall Status

Unknown status

CT.gov ID

NCT03461393

Collaborator

Krankenhaus der Barmherzigen Schwestern Ried (Other)

Enrollment

Location

1.4

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
AMD	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 Design

Study Type:

Observational

Anticipated Enrollment :

11 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Apr 30, 2018

Anticipated Study Completion Date :

May 15, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Visual Acuity [Baseline - 3 months]
6 meter - Decimal

Secondary Outcome Measures

Subjective Satisfaction [Baseline - 3 months]
better - no Change - worse

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus der Barmherzigen Schwestern Ried	Ried Im Innkreis	Upper Austria	Austria	4910

Sponsors and Collaborators

University of Applied Sciences Upper Austria
Krankenhaus der Barmherzigen Schwestern Ried

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Haslwanter, Prof.(FH) Dr., University of Applied Sciences Upper Austria

ClinicalTrials.gov Identifier:

NCT03461393

Other Study ID Numbers:

Uasua

First Posted:

Mar 12, 2018

Last Update Posted:

Mar 20, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Haslwanter, Prof.(FH) Dr., University of Applied Sciences Upper Austria

AMD

Mobile Device

Training

Study Results

No Results Posted as of Mar 20, 2018