Usability of the Software MacuFix for the Categorization of Metamorphopsia

NCT ID: NCT04347564

Last Updated: 2021-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-04

Study Completion Date

2020-09-30

Brief Summary

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

Detailed Description

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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

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Vision Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augenheilkunde Lindenthal

OTHER

Sponsor Role lead

Responsible Party

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Daniela Claessens

Daniela Claessens, Dr.med., M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela Claessens, MD

Role: PRINCIPAL_INVESTIGATOR

Augenheilkunde Lindenthal

Locations

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Augenheilkunde Lindenthal

Cologne, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 34420124 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCT04347564

Identifier Type: REGISTRY

Identifier Source: secondary_id

metacat

Identifier Type: -

Identifier Source: org_study_id

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