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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03461393
Other study ID # Uasua
Secondary ID
Status Recruiting
Phase
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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