AMDETAMDNCT03461393
The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD
An observational study of AMD, run by University of Applied Sciences Upper Austria at 1 site in Austria.
Trial summary
Data collection and observation of changes within AMD patients performing visual training on mobile devices Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- AMD
- What is being tested?
- Medical-Eye-Trainer (MET)
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2018to 15 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All eyes had been affected by dry AMD for 3.5 years or more
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus der Barmherzigen Schwestern Ried
Ried im Innkreis, Upper Austria, 4910
Robert Hörantner, MD, 07752 602 ext. 0, robert.hoerantner@bhs.at
About this study
Data collection and observation of changes within AMD patients performing visual training on mobile devices
Read the 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.
- Conditions
- AMD
- Being tested
- Medical-Eye-Trainer (MET)
- Keywords
- AMD, Mobile Device, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical-Eye-Trainer (MET)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Repetitive Training with Medical-Eye-Trainer (MET) Receives: Device: Medical-Eye-Trainer (MET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
6 meter - Decimal
Measured: Baseline - 3 months
Secondary outcomes (1)
Subjective Satisfaction
better - no Change - worse
Measured: Baseline - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion30 Apr 2018 (estimated)
- Study completion15 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences Upper Austria
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Schwestern Ried
- Responsible party
- Principal investigator, Thomas Haslwanter, University of Applied Sciences Upper Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461393
- Sponsor's protocol ID
- Uasua
- Acronym
- ETAMD
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD
- ClinicalTrials.gov ID
- NCT03461393
- Acronym / sponsor ID
- ETAMD / Uasua
- Conditions
- AMD
- Keywords
- AMD, Mobile Device, Training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of Applied Sciences Upper AustriaUniversity, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Schwestern Ried
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 15 May 2018 (estimated)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data collection and observation of changes within AMD patients performing visual training on mobile devices
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Device: Medical-Eye-Trainer (MET)Repetitive Training with Medical-Eye-Trainer (MET) |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All eyes had been affected by dry AMD for 3.5 years or more
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention Group |
Primary outcome
Visual Acuity
Time frame: Baseline - 3 months
6 meter - Decimal
1 secondary outcome
Subjective Satisfaction
Time frame: Baseline - 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMD, run by University of Applied Sciences Upper Austria at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Hörantner, MD (07752 602 ext. 0, robert.hoerantner@bhs.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: Baseline - 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.