Therapy of Age-related Macular Degeneration Through Training With the Medical Eye Trainer
Conditions: Age-Related Macular Degeneration
Sponsor: Robert Hörantner

Test plan / study protocol
Therapy of Age-related Macular
Degeneration Through Training With
the Medical Eye Trainer 
EK number: 1241/2021 KUK Linz 
Data collection during ongoing therapy
Non-interventional study (NIS)
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version 3, from 2022/01/22
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Table of Contents
1. Responsible employee and addresses...............................................................................................3
1.1. Head of Clinical Trials:.............................................................................................................3
1.2. Test center:................................................................................................................................3
2nd signature:....................................................................................................................................4th
3. Executive summary of the project....................................................................................................5
4. Scientific background....................................................................................................................6th
4.1. General information.................................................................................................................................6th
4.2. Risk-benefit assessment...........................................................................................................................6th
4.3. Examiner information..............................................................................................................................7th
5. Study objective..............................................................................................................................8th
5.1. aim............................................................................................................................................................8th
5.2. Study design.............................................................................................................................................8th
5.3. Target parameters.....................................................................................................................................8th
5.3.1. Primary target point..............................................................................................................................8th
5.3.2. Secondary target point..........................................................................................................................8th
6. Subject recruitment...........................................................................................................................9
6.1. Number of subjects and duration of the study............................................................................................9
6.2. Selection of subjects...................................................................................................................................9
6.3. Inclusion criteria.........................................................................................................................................9
6.4. Exclusion criteria........................................................................................................................................9
7. Medical examinations.....................................................................................................................10
7.1. Personal data.............................................................................................................................................10
7.2. anamnese...................................................................................................................................................10
7.3. Clinical examination.................................................................................................................................10
7.4. Measurement parameters..........................................................................................................................10
7.5. type of application.....................................................................................................................................10
8. Treatment of the subjects.............................................................................................................11th
8.1. Admission to the study...........................................................................................................................11th
8.2. Hospitalization.......................................................................................................................................11th
8.3. Companion therapy................................................................................................................................11th
8.4. documentation........................................................................................................................................11th
9. Course of studies.........................................................................................................................12th
9.1. method....................................................................................................................................................12th
9.2. Recording of compliance.......................................................................................................................12th
9.3. Risk-benefit assessment.........................................................................................................................12th
9.4. Unwanted results....................................................................................................................................12th
9.5. Control body..........................................................................................................................................12th
9.6. Interim evaluation..................................................................................................................................13th
9.7. Termination criteria................................................................................................................................13th
9.8. Termination of the entire study..............................................................................................................13th
10. Biometrics.................................................................................................................................14th
10.1. Biometric authority and institution......................................................................................................14th
10.2. Biometric design..................................................................................................................................14th
10.3. Sample planning..................................................................................................................................14th
10.4. Data acquisition and evaluation...........................................................................................................14th
10.5. Statistical Methods...............................................................................................................................14th
11. Changes to the study plan..........................................................................................................15th
12. Ethical and Legal Issues...............................................................................................................16
12. Insurance...................................................................................................................................17th
13. Archiving and data protection...................................................................................................18th
14. Literature...................................................................................................................................19th
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1. responsibler Collaborater and addresses
1.1. Head of Clinical Trials:
Robert Hörantner
Ophthalmologist
Castlessmountain 1
4910 Ried
Telephone: 07752 602 84282
E-mail: robert.hoerantner@bhs.at
1.2. Test center: 
Eye department of the hospital of the Merciful Sisters in Ried
Castlessmountain 1
4910 Ried
Phone: 07752 602
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2. signature:
Robert Hörantner
Hospital of the Sisters 
of Mercy in Ried
Signature:
Digital signature
Date:
6/8/2021
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3. Short version of the project
With the Medical Eye Trainer (MET) training system, patients suffering from dry age-related 
macular degeneration (AMD) are treated as part of the clinical routine. The MET system is an 
application (software) for a standard multimedia device such as a smartphone or tabletC.omputer. 
The people affected by the disease treat themselves independently once a day for 90 seconds. The 
planned study will not introduce any new indications or therapynused. Only data from ongoing 
therapies are collectedt, around to check the effect of the treatment. It haturns around a Non-
interventional study (NIS). It doesn't come to any sstudy-specific risk increase, since there are no 
study-related interventions that go beyond the clinicalhey routine.
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4. Scientific background
4.1. General information
AMD is a disease of the eye that is widespread worldwide. According to the Gutenberg health 
study, around 7,000,000 people in Germany suffer from it. The figures for Austria can be assumed 
to be 700,000 due to the smaller population. A distinction is made between two forms of AMD, the 
wet form with 15% and the dry form with 85%. Both types have a high risk of developing 
significant visual impairment quickly. There are currently only a few therapeutic options for the dry 
form of the disease. Essentially, nutritional supplement therapy should be mentioned here. This 
treatment can only reduce the progression of deterioration in 10% of affected people, but it does 
have a significant side effect profile. This raises the question of completely different treatment 
approaches. Because of this, theM.edical E.ye Trainer (MET). This is a training device that can 
easily be used by yourself. The purpose of this new therapy is not to attempt to cure AMD. The eye 
and brain are trained to better deal with the disease. In a first study on 17 eyes, an improvement in 
visual performance could even be achieved in 11 cases, the remaining 6 cases showed a stable 
situation. In no case did it deteriorate. Thus it was possible for the first time not only to slow down 
this disease, but even to improve ithen. In a second study with a planned number of 150 
examinations, this positive effect is to be investigated further. A calculation based on the results of 
the first study with G * Power gives an optimal number of 150 examinations.
4.2. Risk-benefit assessment 
The MET system is in clinicalmStandard use. The patients are subjected to routine checks at the 
usual intervals. In the planned study there is only one data collection and evaluation. There is 
therefore no increase in risk. With this data evaluation, the effect of the therapy can be shown more 
precisely.
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4.3. Examiner information
The information collected corresponds to the usual clinical control of the participants.
Only one examiner is planned for the study, so no special information transfer is necessary.
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5. Study objective
5.1. aim
The study aims to determine the therapeutic effect of MET im Check ongoing use on the patient. 
5.2. Study design
This observational study corresponds to a non-interventional study (NIS) and can therefore not be 
assigned to a normal phase of a study (I-IV).
The study is being carried out at a center.
5.3. Target parameters
5.3.1. Primary target point
Eyesight improvement
5.3.2. Secondary target point
Improving the quality of life through better handling of the disease.
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6. Subject recruitment
6.1. Number of subjects and duration of the study
According to the results of the first study, the calculation with the G * Power system results in a 
number of 150 eyes. For the study, that number was doubled. The study is planned to last 6 months.
6.2. Selection of subjects
People who are already in therapy. can be taken into account in the data evaluation. In addition, the 
inclusion of additional test subjects is required. ArounddTo keep the recruitment phase short, 
general practitioners will be informed of the possibility of referring their patients to the study.
6.3. Inclusion criteria
People with dry AMD are included regardless of age. Thus, this value is given as 20-99 years.
6.4. Exclusion criteria
Exclusion criteria are wet AMD, epilepsy and double vision. Other eye diseases are not a 
problemrepresent. 
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7. Medical examinations
7.1. Personal data
Only the age is recorded.
7.2. anamnese
Duration of illness, previous therapies.
7.3. Clinical examination
OCT, eyesight, eye status.
7.4. Measurement parameters
Eyesight, fundus.
7.5. type of application
Therapy will from the patient Carried out independently daily and takes 90 seconds per eye.
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8. Treatment of the subjects
8.1. Admission to the study
All participants are informed about the study, effects, side effects and risks by means of an 
information sheet written for the study together with the supervising doctor. Consent is given by 
mutual signature with clarity and consent.
8.2. Hospitalization
no
8.3. Companion therapy
None
8.4. documentation
The encrypted data can only be viewed and further processed by the examiner. It'll be a complete 
oneA.nanonymization of the original data is carried out after the data collection has ended. The 
study will be athttps://clinicaltrials.govregistered and dealt with according to the specifications. 
These defaults are also used for the publication.
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9. Course of studies
9.1. method
The participants will examined in the Ried im Innkreis hospital and treated with MET. Apart from 
the usual eye examinations for AMD, none are eligible for the studyzadditional measures necessary.
An assessment of the fundus is also accompanied by a Optical C.oherence Tomography (OCT) 
confirmed the diagnosis. The visual performance for distance (5-6m) and for near (40cm) is 
determined as an essential factor in the development of the disease.
Participants need their own mobile electronic device with the Apple IOS® or Android® operating 
system. The MET training system in the form of software will be made available for the duration of 
the study. Therapy willfrom the patient Carried out independently daily and takes 90 seconds per 
eye. A success check is planned after two months. The above investigations are repeated here.In 
addition, the patients are asked about their condition.
9.2. Recording of compliance
By questioning
9.3. Risk-benefit assessment
The first study showed a 34% improvement in eyesight as a result of the therapy; there were no side
effects or undesirable effects.
9.4. Unwanted results 
By training kcanin rare cases dizziness or double vision are triggered. In previous studies in 
children it could be shown that these side effects reappear immediately after discontinuation of 
therapygo awayn. There were no side effects in the first study. The study will be carried out if any 
side effect occursen ended immediately. 
The participant recognizes the side effects himself and is requested to stop the training immediately 
and contact the test center.
9.5. Control body
onGaround the studieconception nott provided.
9.6. Interim evaluation
Not provided.
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9.7. Termination criteria
If undesirable results occur or at the request of the participants.
9.8. Abort the entiren study 
For the good and in the interest of the test subjects, the investigator can terminate the study at any 
time if severe side effects or other unforeseeable circumstances occur. In this case, the ethics 
committee will be informed.
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10. biometrics 
10.1. Biometric authority and institution
Prof. Dr. Wolfgang Stürzlinger, VVISE LabD.irector, Simon Fraser University, BC Canada
10.2. Biometric design 
Longitudinal comparison of the change
10.3. Sample planning 
According to the results of the first study, the calculation with the G * Power system results in a 
number of 150 eyes. For the study, that number was doubled.
10.4. Data acquisition and evaluation
Entry in Libre Office spreadsheet ® Evaluation in PSPP ®.
10.5. Statistical Methods 
T test, Wilcoxon, Smirnov
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11. Changes to the study plan 
Every change to the test plan must be added as an amendment to every test plan in circulation. All 
protocol changes must be reported to the ethics committee. In the case of changes to the study plan 
that are not exclusively of a formal nature and contain changes that are relevant to the test subject, a
renewed vote of the ethics committee must be obtained. The patients / test persons must be 
informed of any changes to the study conditions as part of the information and consent. Any 
complications and serious adverse events in the course of the research project must be reported to 
the ethics committee immediately.
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12. Ethical and Legal Issues 
When carrying out the study, in addition to the Declaration of Helsinki (as amended), the following 
guidelines and laws must be observed: 
Medical Devices Act (MPG) 
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12. Insurance 
It is about eggno Non-interventional study (NIS). These studies were formerly known as the 
"Observatoryungen ". There was no study-specific increase in riskG, since there are no study-
related interventions that go beyond clinical routine. No-fault insurance is taken out for the usual 
security and legal protection of employees.
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13. Archiving and data protection 
The anonymisierThe most recent data are archived and backed up in accordance with the General 
Data Protection Regulation. 
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14. literature
1. Effect of repetitive visual training in patients with dry age-related macular degeneration
To investigate the efficacy of repetitive visual training with large-field visual stimulation for 
patients with dry age-related macular degeneration (AMD). 
Dr. Robert Hörantner, Jürgen Wolfsgruber, Gerald Stürzlinger... in Spectrum of 
ophthalmology(2021)
2. The Dry Form of Age-Related Macular Degeneration (AMD): The Current Concepts of 
Pathogenesis and Prospects for Treatment.
Zając-Pytrus HM, Pilecka A, Turno-Kręcicka A, Adamiec-Mroczek J, Misiuk-Hojło M.
Adv Clin Exp Med. 2015 Nov-Dec; 24 (6): 1099-104. doi: 10.17219 / acem / 27093.
3. Age-related macular degeneration therapy: a review.
Ammar MJ, Hsu J, Chiang A, Ho AC, Regillo CD.
Curr Opin Ophthalmol. 2020 May; 31 (3): 215-221. doi: 10.1097 / ICU.0000000000000657.PMID: 
32205470
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