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

AMD Clinical Trial

— ETAMD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03461393
• Other study ID #: Uasua
• Status: Recruiting
• First received: March 5, 2018
• Last updated: March 19, 2018
• Start date: April 1, 2018
• Est. completion date: May 15, 2018

Study information

• Verified date: March 2018
• Source: University of Applied Sciences Upper Austria
• Contact: Robert Hörantner, MD
• Phone: 07752 602
• Email: robert.hoerantner[@]bhs.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: May 15, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• AMD

Intervention

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.

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Schwestern Ried	Ried Im Innkreis	Upper Austria

Sponsors (2)

Lead Sponsor	Collaborator
University of Applied Sciences Upper Austria	Krankenhaus der Barmherzigen Schwestern Ried

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	6 meter - Decimal	Baseline - 3 months
Secondary	Subjective Satisfaction	better - no Change - worse	Baseline - 3 months