Usability of the Software MacuFix for the Categorization of Metamorphopsia (MacuFix)

May 15, 2021 updated by: Daniela Claessens, Augenheilkunde Lindenthal

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"

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50931
        • Augenheilkunde Lindenthal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 persons, age at least 18 years, BVCA at least 20/200

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augenheilkunde Lindenthal

Investigators

  • Principal Investigator: Daniela Claessens, MD, Augenheilkunde Lindenthal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

April 11, 2020

First Submitted That Met QC Criteria

April 11, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • metacat
  • NCT04347564 (Registry Identifier: ClinicalTrials.gov)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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