NCT02775396

Brief Summary

With the increasing reliance on tablet computers and smartphones in daily life, it is important to determine whether and how the prolonged usage of these handheld digital devices influences the working habits and refractive status. This study aimed to determine the effects of wearing conventional single-vision lenses vs. new progressive addition lenses on the working distance and refractive status while playing interactive video game in Chinese pre-presbyopic adult computer users.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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

September 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

May 11, 2016

Last Update Submit

May 16, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in near working distance measured by an automatic ultrasound sensor

    Near working distances were measured continuously over a 30-minute interval while the participant was playing computer games using an iPad tablet computer. The mode of the accumulative working distances was analyzed for each 30-minute interval collected immediately after the lens delivery and one-month after the lens wear. Absolute and relative changes in the working distances were analyzed and compared between two lens designs.

    Change in near working distance after one month of lens wear

  • Change in refractive status measured by an automatic refractometer

    Refractive status was measured before and after the participant played a 30-minute computer games using an iPad tablet computer. The refractive status shift (post-task refractive status minus pre-task refractive status) was calculated for each 30-minute game play immediately after the lens delivery and one-month after the lens wear. Absolute and relative changes in the refractive shirt were analyzed and compared between two lens designs.

    Change in refractive status shift after one month of lens wear

Study Arms (1)

Adult computer user

EXPERIMENTAL

Wearing each of the two spectacle lens designs for one month in random sequence

Device: Spectacle lens

Interventions

Wearing a spectacle lens design with corrective prescription power while playing computer game using an iPad tablet computer. Two lens designs were prescribed for each participant: the conventional single-vision lens and a new progressive addition lens designed for handheld digital device. Primary outcome measures were performed immediately after each lens delivery and one-month of lens wear.

Adult computer user

Eligibility Criteria

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

You may qualify if:

  • Hong Kong Chinese
  • Computer users (computer usage \>2hours/day)
  • Spherical-equivalent refractive errors between plano and -9.00D and cylindrical power ≤2.50D

You may not qualify if:

  • Anyone with visual acuity worse than 0 logMAR, anisometropia more than 2.00D, abnormal accommodative function, wearing rigid contact lens, and a history of ocular surgery and pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kee CS, Leung TW, Kan KH, Lam CH. Effects of Progressive Addition Lens Wear on Digital Work in Pre-presbyopes. Optom Vis Sci. 2018 May;95(5):457-467. doi: 10.1097/OPX.0000000000001211.

Study Officials

  • Chea-su Kee, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 17, 2016

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05