NCT03831919

Brief Summary

Many people using computers or digital devices (e.g., smartphones or tablets) experience eyestrain and this has been called Computer Vision Syndrome (CVS) or Digital Eye Strain. Spectacle lens manufacturers have designed products to alleviate the symptoms of CVS. One such product, designed by Hoya (SYNC III), aims to do this by providing accommodative support. The present study is a parallel group double-masked RCT of people with CVS. One group will receive Hoya SYNC III lenses and the other (control) group single vision (SV) lenses. The main aims are to evaluate whether:

  1. 1.binocular vision and accommodative functions at baseline can predict participants who benefit from SYNC III design lenses;
  2. 2.the wearing of SYNC III design lenses is associated with any changes in binocular and accommodative functions at 6 months of follow-up;
  3. 3.the wearing of lenses with accommodative support reduce the symptoms of computer vision syndrome at 3 and 6 months of follow-up.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

January 23, 2019

Last Update Submit

July 28, 2020

Conditions

Computer Vision Syndrome

Keywords

ocular accommodation

Outcome Measures

Primary Outcomes (7)

  • Change in CVS-Q

    Computer vision syndrome quality of life instrument

    Baseline, three-month follow-up, six-month follow-up

  • Change in heterophoria

    Dissociated heterophoria using Prentice test.

    Baseline, three-month follow-up, six-month follow-up

  • Change in aligning prism

    Associated heterophoria using Mallett unit

    Baseline, three-month follow-up, six-month follow-up

  • Change in near point of convergence

    NPC, push-up

    Baseline, three-month follow-up, six-month follow-up

  • Change in amplitude of accommodation

    push-up

    Baseline, three-month follow-up, six-month follow-up

  • Change in accommodative lag

    MEM retinoscopy

    Baseline, three-month follow-up, six-month follow-up

  • Change in accommodative facility

    +-1.50 flippers

    Baseline, three-month follow-up, six-month follow-up

Secondary Outcomes (2)

  • Fusional reserves

    Baseline, three-month follow-up, six-month follow-up

  • Stereopsis

    Baseline, three-month follow-up, six-month follow-up

Study Arms (2)

SYNC III accommodative support lenses

EXPERIMENTAL

Wear spectacles with SYNC III accommodative support lenses (add +0.75)

Device: SYNC III

control

PLACEBO COMPARATOR

Wear single vision spectacles (no add)

Device: single vision lenses

Interventions

SYNC IIIDEVICE

Hoya SYNC III design spectacle lenses

SYNC III accommodative support lenses
single vision lensesDEVICE

single vision spectacle lenses with no addition

control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40 years;
  • In a typical working day, spends at least 2 hours viewing digital devices (e.g., desktop, laptop, tablet, smart phone);
  • Symptoms associated with the use of digital devices, quantified as a score of six points or more on the CVS-Q questionnaire instrument;1
  • Use of spectacles, at least 6, months previous to the beginning of the study;
  • Refractive error between +6.00 to -8.00 with cyl up to 4.00DC.

You may not qualify if:

  • Previous use of accommodative support lenses
  • Ocular pathology requiring referral to an ophthalmologist
  • Wears contact lenses when using computers
  • Strabismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alicante

Alicante, 03080, Spain

Location

Institute of Optometry

London, SE1 6DS, United Kingdom

Location

Related Publications (1)

  • Segui Mdel M, Cabrero-Garcia J, Crespo A, Verdu J, Ronda E. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol. 2015 Jun;68(6):662-73. doi: 10.1016/j.jclinepi.2015.01.015. Epub 2015 Jan 28.

    PMID: 25744132BACKGROUND

Study Officials

  • Bruce Evans, PhD

    Institute of Optometry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2019

First Posted

February 6, 2019

Study Start

January 7, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

the plan is to share anonymised data

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
within 1 year of end of study for unspecified period
Access Criteria
Genuine requests from researchers Only anonymised data will be provided

Locations

ES(1)GB(1)