Trial Outcomes & Findings for Usability of the Software MacuFix for the Categorization of Metamorphopsia (NCT NCT04347564)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

45 participants

Primary outcome timeframe

1 day

Results posted on

2021-05-18

Participant Flow

Of 75 patients questioned, 45 participated in the study.

Participant milestones

Participant milestones
Measure	Initial Population As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June, 2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain optical coherence tomography was performed. After performing the MacuFix® test all study patients filled out the questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test or they could download the test as an app for use with an iPad or smartphone (MacuFix group). 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI VFQ-25 once more.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Initial Population n=45 Participants As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the pseudonymised questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
Age, Categorical <=18 years	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=45 Participants
Age, Categorical >=65 years	33 Participants n=45 Participants
Sex: Female, Male Female	18 Participants n=45 Participants
Sex: Female, Male Male	27 Participants n=45 Participants
Region of Enrollment Germany	45 Participants n=45 Participants
BCVA	0.6 Snellen decimal STANDARD_DEVIATION 0.25 • n=45 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 45 patients

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)

Outcome measures

Outcome measures
Measure	Initial Population n=45 Participants As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.	Amsler Grid or no Home Test 12-14 weeks after the study day patients using the Amsler Grid as a home test or no home test were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
Score of System Usability Scale (SUS) Questionnaire	76.7 score on a scale Standard Deviation 15.5	—

SECONDARY outcome

Timeframe: 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.

Population: difference in frequency of using the Amsler Grid or the app MacuFix® measured as the time interval (days) between two measurements to assess 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.

Outcome measures

Outcome measures
Measure	Initial Population n=45 Participants As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.	Amsler Grid or no Home Test 12-14 weeks after the study day patients using the Amsler Grid as a home test or no home test were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
Median Time Interval (in Days) Between Two Self-test Measurements (MakuFix or Amsler Respectively) to Assess the Test Adherence	13 days Interval 3.82 to 23.37	—

SECONDARY outcome

Timeframe: The validated questionnaire "National Eye Institute Visual Function Questionnaire-25" (NEI VFQ-25) was used at baseline and after 3 months.

Population: Of 45 patients included in the study, 29 subjects completed the questionnaire-25 NEI VFQ-25 before the study day and after 3 months of app use ("app user" group: 20 subjects) or 3 months of non-use ("comparison group" group: 8 performed the Amsler test, 1 did not use a self-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.

Outcome measures

Outcome measures
Measure	Initial Population n=20 Participants As part of a routine examination, each participating patient carried out the MacuFix test with each eye with adequate near correction once in the period 4th May, 2020 - 30th June,2020. In addition, BCVA was measured, patients filled out the vision-related questionnaire NEI VFQ-25, patients were asked about the frequency of use of the Amsler test, a retinal examination and a spectral domain OCT was performed. After performing the MacuFix® test all study patients filled out the questionnaire SUS. If they were interested, the patients were given a link for free use of MacuFix® as a home test on a PC for future use of the test. Alternatively, the patients could download the test as an app for use with an iPad or smartphone. 3 months after the study day patients were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.	Amsler Grid or no Home Test n=9 Participants 12-14 weeks after the study day patients using the Amsler Grid as a home test or no home test were asked whether they agreed to be interviewed about the frequency of using a home test and whether they were willing to answer the questionnaire NEI-VFQ-25 once more.
Change of Vision-related Quality of Life (NEI VFQ-25, Subscale 7) After Use of the App MacuFix Versus Amsler Grid/no Test	20.31 score on a scale Interval 10.25 to 30.37	-3.47 score on a scale Interval -16.24 to 9.3

Adverse Events

Initial Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniela Claessens

Augenheilkunde Lindenthal

Phone: 017229227962

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place