Usability of the Software MacuFix for the Categorization of Metamorphopsia

NCT04347564 | Completed Results

• 2 other identifiers: metacatNCT04347564
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The usability of a novel test to categorize a distorted visual impression (metamorphopsia) is examined with the questionnaire "SUS"

Conditions

Vision Disorders

Keywords

metamorphopsia; age-related macular degeneration; diabetic macular edema; home test

Outcome Measures

Primary Outcomes (1)

• 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)

  1 day

Secondary Outcomes (2)

• Median Time Interval (in Days) Between Two Self-test Measurements (MakuFix or Amsler Respectively) to Assess the Test Adherence

  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 at baseline and after 3 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Augenheilkunde Lindenthal: lead

Study Sites (1)

Augenheilkunde Lindenthal

Cologne, 50931, Germany

Location

Related Publications (1)

• 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.

  PMID: 34420124 DERIVED

MeSH Terms

Conditions

Vision Disorders; Macular Degeneration

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Limitations and Caveats

Comparability of MacuFix® and the Amsler Grid, is to some extent limited, because MacuFix® tests the central 4° of the visual field whereas the Amsler Grid examines 10° when used in the intended distance.

Results Point of Contact

• Title: Daniela Claessens
• Organization: Augenheilkunde Lindenthal

daniela.claessens@gmx.de

017229227962

Study Officials

• Daniela Claessens, MD

  Augenheilkunde Lindenthal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniela Claessens, Dr.med., M.Sc.

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 15, 2020
• Study Start: May 4, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-05

Locations

DE (1)