Clinical trial NCT04347564: Usability of the Software MacuFix for the Categorization of Metamorphopsia
Official title: Usability of the Software MacuFix for the Categorization of Metamorphopsia and Evaluation of Patient Adherence Compared to the Amsler Grid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision Disorders
Keywords: metamorphopsia
age-related macular degeneration
diabetic macular edema
home test
Lead sponsor: Augenheilkunde Lindenthal
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 persons, age at least 18 years, BVCA at least 20/200

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

1. Distorted visual impression in at least one eye, detected with Amsler grid:
2. Best-corrected visual acuity (BCVA): at least 20/200; age over 18 years; presence of a declaration of consent to participate in the study

Exclusion Criteria:

No distorted visual impression in both eyes; best corrected visual acuity under 0.1; age under 18 years

Primary outcomes:
measure: Score of System Usability Scale (SUS) Questionnaire
timeFrame: 1 day
Secondary outcomes:
measure: Median Time Interval (in Days) Between Two Self-test Measurements (MakuFix or Amsler Respectively) to Assess the Test Adherence
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.
measure: Change of Vision-related Quality of Life (NEI VFQ-25, Subscale 7) After Use of the App MacuFix Versus Amsler Grid/no Test
timeFrame: The validated questionnaire "National Eye Institute Visual Function Questionnaire-25" (NEI VFQ-25) was used at baseline and after 3 months.
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Augenheilkunde Lindenthal
Study officials:
affiliation: Augenheilkunde Lindenthal
name: Daniela Claessens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.