NCT02656953

Brief Summary

The aim of this study is to investigate the impact of wearing visual display units (VDU) lenses versus progressive lenses on musculoskeletal and visual complaints in VDU workers with work related neck complaints. This will be evaluated by means of questionnaires (Neck Disability Index and Visual Fatigue Questionnaire), muscle tone, elasticity and stiffness, pressure pain threshold and 2D video analysis of head posture during a VDU task.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

December 18, 2015

Last Update Submit

December 5, 2022

Conditions

Keywords

VDU workersVDU lensesNeck complaintsVisual complaints

Outcome Measures

Primary Outcomes (2)

  • Change in functionality using the Neck disability index (NDI)

    The NDI consists of ten questions concerning pain and daily living activities such as lifting, reading, driving, etc. and the maximum score is 50.

    At baseline and six months

  • Change in visual complaints using the Visual Fatigue Questionnaire

    The questionnaire consists of 15 questions which have to be answered on a visual analogue scale ranging from zero to ten. It enquires eye strain, impaired vision, impaired eye surface and problems of the outside of the eyes, headache for example. The maximum score is 10.

    At baseline and six months

Secondary Outcomes (5)

  • Change in muscle elasticity by using the MyotonPRO® device

    At baseline and six months

  • Change in muscle stiffness by using the MyotonPRO® device

    At baseline and six months

  • Change in muscle tone by using the MyotonPRO® device

    At baseline and six months

  • Change in pressure pain threshold by using the WagnerTM FDX 50 hand-held pressure algometer

    At baseline and six months

  • Change in head posture during a VDU task by means of 2D video analysis

    At baseline and six months

Study Arms (2)

VDU lenses

EXPERIMENTAL

VDU lenses provide a clear vision of the intermediate zone at a distance of approximately 70 centimeters, which is closer than distant vision at a distance of more than 2 meters (e.g. driving), but further than near vision at a distance of 40 centimeters (e.g. reading), so the computer screen is seen clear without the need for excessive focusing effort or bad postures. In this study Zeiss® Officelens Plus lenses with a Silhouette® frame were used.

Other: VDU lenses (Zeiss® Officelens Plus)

Progressive lenses

ACTIVE COMPARATOR

Progressive lenses or multifocal lenses provide a continuous range of focal power between near and far distances.Progressive lenses have some lens power for the intermediate zone as well, but this zone might not be large enough for comfortable and ergonomic computer work. In this study Zeiss® Multifocal Precision Plus lenses with a Silhouette® frame were used.

Other: Progressive lenses (Zeiss® Multifocal Precision Plus)

Interventions

The treatment group (n=22) was given progressive VDU glasses (Zeiss® Officelens Plus), specially designed for VDU work. The participants were asked to wear their new glasses for six months during computer work.

VDU lenses

The comparison group (n=18) was given progressive glasses (Zeiss® Multifocal Precision Plus). The participants were asked to wear their new glasses for six months during computer work.

Progressive lenses

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 4 hours a day and 20 hours a week of VDU work
  • Work related neck/shoulder complaints
  • Difference in spectacle correction for presbyopia and myopia of minimum 1.5 dioptres

You may not qualify if:

  • Active eye disease that can't be corrected with eyeglasses
  • Drugs that strongly influence eye or muscle function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Cagnie, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2015

First Posted

January 15, 2016

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share