Vision DisordersMacuFixNCT04347564
Usability of the Software MacuFix for the Categorization of Metamorphopsia
An observational study of Vision Disorders, run by Augenheilkunde Lindenthal at 1 site in Germany.
Trial summary
The usability of a novel test to categorize a distorted visual impression (metamorphopsia) is examined with the questionnaire "SUS" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vision Disorders
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 4 May 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 persons, age at least 18 years, BVCA at least 20/200
Who may be able to join
- Distorted visual impression in at least one eye, detected with Amsler grid:
- Best-corrected visual acuity (BCVA): at least 20/200; age over 18 years; presence of a declaration of consent to participate in the study
Who cannot join
- No distorted visual impression in both eyes; best corrected visual acuity under 0.1; age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability of the Software MacuFix for the Categorization of Metamorphopsia and Evaluation of Patient Adherence Compared to the Amsler Grid
The usability of a novel test to categorize a distorted visual impression (metamorphopsia) is examined with the questionnaire "SUS"
Read the detailed description
Introduction Diseases of the retinal centre (macula) can lead to a distorted visual impression (metamorphopsia). The usability of a novel on-screen test to categorize metamorphopsia is to be examined with the questionnaire "SUS" to determine how user-friendly the software is perceived.
Purpose To examine the usability of the software for persons perceiving metamorphopsia employing the questionnaire SUS.
Aim of the work Improvement of the software in terms of user-friendliness.
Methods For this observational pilot study, 30 persons are to be recruited from the patient pool of a private practice.
Primary endpoint: Score of the SUS questionnaire.
Each participating person performs the test once with each eye wearing appropriate near correction. The test shows on a screen 4 square fields with a grid pattern of horizontal and vertical lines. All 4 fields have lines that are partially distorted. The task of the test person is to select the field with more distinctively distorted lines when viewed with one eye.This selection must be made at least 10 times per eye: an algorithm determines the smallest correctly named distortion difference. Afterwards each person answers the System Usability Scale (SUS) questionnaire, SUS contains five positive and five negative statements on the usability of the system being evaluated. For each statement, the study participant gives his or her approval or rejection in the form of a scale ranging from 1= "strong approval" to 5= "strong rejection" of the statement. The results of the SUS questionnaire are used to calculate a numerical value (SUS score).
- Conditions
- Vision Disorders
- Keywords
- metamorphopsia, age-related macular degeneration, diabetic macular edema, home test
- Medical subject headings
- Vision Disorders, Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of System Usability Scale (SUS) Questionnaire
Patients filled out the SUS questionnaire immediately after completing the MacuFix test. SUS consists of ten statements each with five possible answers ranging from complete rejection to complete agreement. For each statement, the participant gives his or her approval or rejection in the form of a scale ranging from 1=strong approval to 5=strong rejection. The results of the SUS questionnaire are used to calculate a numerical value (SUS score).The results can have a value between 0 (worst application imaginable) and 100 (best application imaginable)
Measured: 1 day
Secondary outcomes (2)
Median Time Interval (in Days) Between Two Self-test Measurements (MakuFix or Amsler Respectively) to Assess the Test Adherence
After a positive vote by the Ethics Committee of the North Rhine Medical Association (No. 2020057) 45 patients were included in the study from 4th May, 2020 - 30th June, 2020. Based on the amendment approval of the competent ethics committee (No. 600213225) participating persons were offered to use the App MacuFix® as a home test and to start a prospective, controlled study to examine the adherence using a self-test and evaluate the vison-related quality of life.
On the study day and 3 months later each patient was asked about the frequency of use of the Amsler test.
The time interval given by the patient between two Amsler Tests (Amsler group) or two MacuFix texts (MacuFix group) was assessed in days.
Measured: On the study day and 3 months after the study day, patients were asked how many days usually elapsed after a test with the method they chose until the next time they used this test method.
Change of Vision-related Quality of Life (NEI VFQ-25, Subscale 7) After Use of the App MacuFix Versus Amsler Grid/no Test
The validated questionnaire "National Eye Institute Visual Function Questionnaire-25" (NEI VFQ-25) was used to measure vision-related quality of life. The values in the questionnaire can take values from 0 to 100. High values in this questionnaire correspond to a better quality of life, low values to a poor quality of life. The 25 questions of this questionnaire can be assigned to 12 scales.
Measured: The validated questionnaire "National Eye Institute Visual Function Questionnaire-25" (NEI VFQ-25) was used at baseline and after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start4 May 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vision DisordersStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augenheilkunde Lindenthal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Claessens, Augenheilkunde Lindenthal
- Investigators
- Daniela Claessens, MD, Principal investigator, Augenheilkunde Lindenthal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347564
- Sponsor's protocol ID
- metacat
- Other IDs
- NCT04347564
- Acronym
- MacuFix
- Status last verified
- May 2021
- First submitted
- 11 Apr 2020
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Claessens D, Ichhpujani P, Singh RB. MacuFix(R) versus Amsler grid for metamorphopsia categorization for macular diseases. Int Ophthalmol. 2022 Jan;42(1):229-238. doi: 10.1007/s10792-021-02017-3. Epub 2021 Aug 22.
PubMed 34420124
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of the Software MacuFix for the Categorization of Metamorphopsia and Evaluation of Patient Adherence Compared to the Amsler Grid
- ClinicalTrials.gov ID
- NCT04347564
- Acronym / sponsor ID
- MacuFix / metacat
- Conditions
- Vision Disorders
- Keywords
- metamorphopsia, age-related macular degeneration, diabetic macular edema, home test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Augenheilkunde LindenthalUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The usability of a novel test to categorize a distorted visual impression (metamorphopsia) is examined with the questionnaire "SUS"
Detailed description
Introduction Diseases of the retinal centre (macula) can lead to a distorted visual impression (metamorphopsia). The usability of a novel on-screen test to categorize metamorphopsia is to be examined with the questionnaire "SUS" to determine how user-friendly the software is perceived.
Purpose To examine the usability of the software for persons perceiving metamorphopsia employing the questionnaire SUS.
Aim of the work Improvement of the software in terms of user-friendliness.
Methods For this observational pilot study, 30 persons are to be recruited from the patient pool of a private practice.
Primary endpoint: Score of the SUS questionnaire.
Each participating person performs the test once with each eye wearing appropriate near correction. The test shows on a screen 4 square fields with a grid pattern of horizontal and vertical lines. All 4 fields have lines that are partially distorted. The task of the test person is to select the field with more distinctively distorted lines when viewed with one eye.This selection must be made at least 10 times per eye: an algorithm determines the smallest correctly named distortion difference. Afterwards each person answers the System Usability Scale (SUS) questionnaire, SUS contains five positive and five negative statements on the usability of the system being evaluated. For each statement, the study participant gives his or her approval or rejection in the form of a scale ranging from 1= "strong approval" to 5= "strong rejection" of the statement. The results of the SUS questionnaire are used to calculate a numerical value (SUS score).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 persons, age at least 18 years, BVCA at least 20/200
Key inclusion criteria (2 listed)
- Distorted visual impression in at least one eye, detected with Amsler grid:
- Best-corrected visual acuity (BCVA): at least 20/200; age over 18 years; presence of a declaration of consent to participate in the study
Key exclusion criteria (1 listed)
- No distorted visual impression in both eyes; best corrected visual acuity under 0.1; age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score of System Usability Scale (SUS) Questionnaire
Time frame: 1 day
Patients filled out the SUS questionnaire immediately after completing the MacuFix test. SUS consists of ten statements each with five possible answers ranging from complete rejection to complete agreement. For each statement, the participant gives his or her approval or rejection in the form of a scale ranging from 1=strong approval to 5=strong rejection. The results of the SUS questionnaire are used to calculate a numerical value (SUS score).The results can have a value between 0 (worst application imaginable) and 100 (best application imaginable)
2 secondary outcomes
Median Time Interval (in Days) Between Two Self-test Measurements (MakuFix or Amsler Respectively) to Assess the Test Adherence
Time frame: On the study day and 3 months after the study day, patients were asked how many days usually elapsed after a test with the method they chose until the next time they used this test method.
Change of Vision-related Quality of Life (NEI VFQ-25, Subscale 7) After Use of the App MacuFix Versus Amsler Grid/no Test
Time frame: The validated questionnaire "National Eye Institute Visual Function Questionnaire-25" (NEI VFQ-25) was used at baseline and after 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34420124Claessens D, Ichhpujani P, Singh RB. MacuFix(R) versus Amsler grid for metamorphopsia categorization for macular diseases. Int Ophthalmol. 2022 Jan;42(1):229-238. doi: 10.1007/s10792-021-02017-3. Epub 2021 Aug 22.
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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.
Daniela Claessens, MD principal investigator
Augenheilkunde Lindenthal
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 Vision Disorders, run by Augenheilkunde Lindenthal at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 18 May 2021. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of System Usability Scale (SUS) Questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347564, which also lists 1 linked publication.
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 18 May 2021.