- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02775396
Effects of Wearing Progressive Addition Lens on Working Distance and Refractive Status in Adult Computer Users
May 16, 2016 updated by: The Hong Kong Polytechnic University
Effects of Wearing a New Progressive Addition Lens on Working Distance and Refractive Status in Adult Chinese Computer Users
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chinese adult computer users were recruited from two age cohorts.
They were prescribed, in random order, with conventional single-vision lenses and progressive addition lenses designed for handheld digital display devices (iPad).
Basic ocular parameters were measured through a comprehensive eye examination at the baseline visit.
Working distance and refractive shift were measured immediately after delivering the lenses and after one month of lens wear.
Working distance were recorded with an automatic ultrasound sensor while the participants were playing a 30-minute video game.
Refractive-error shift before and after playing the video game were measured with an open-field autorefractor in both eyes and averaged.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hong Kong Chinese
- Computer users (computer usage >2hours/day)
- Spherical-equivalent refractive errors between plano and -9.00D and cylindrical power ≤2.50D
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adult computer user
Wearing each of the two spectacle lens designs for one month in random sequence
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in near working distance measured by an automatic ultrasound sensor
Time Frame: Change in near working distance after one month of lens wear
|
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
Time Frame: Change in refractive status shift after one month of lens wear
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
May 16, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Estimate)
May 17, 2016
Last Update Submitted That Met QC Criteria
May 16, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- P14-0085
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Video Game Play Using Handheld Computer
-
Indiana UniversityThe Center for Successful Parenting Video Research CenterUnknownBrain Functioning and Violent Video Game PlayUnited States
Clinical Trials on Spectacle lens
-
nthalmic Pty LtdBrighten Optix CorporationActive, not recruiting
-
Neurolens Inc.CompletedHeadache | Computer Vision Syndrome | Convergence Insufficiency | Binocular Vision DisorderUnited States
-
Neurolens Inc.TerminatedComputer Vision Syndrome | Convergence Insufficiency | Binocular Vision DisorderUnited States
-
HOYA Lens Thailand LTD.Recruiting
-
HOYA Lens Thailand LTD.Active, not recruiting
-
Essilor InternationalCompleted
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityActive, not recruiting
-
SightGlass Vision, Inc.Recruiting
-
SightGlass Vision, Inc.Active, not recruiting
-
SightGlass Vision, Inc.Active, not recruitingJuvenile MyopiaUnited States, Canada