Video Game Play Using Handheld ComputerNCT02775396
Effects of Wearing Progressive Addition Lens on Working Distance and Refractive Status in Adult Computer Users
A study testing Spectacle lens in people with Video Game Play Using Handheld Computer, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Video Game Play Using Handheld Computer
- What is being tested?
- Spectacle lens
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hong Kong Chinese
- Computer users (computer usage >2hours/day)
- Spherical-equivalent refractive errors between plano and -9.00D and cylindrical power ≤2.50D
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Video Game Play Using Handheld Computer
- Being tested
- Spectacle lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacle lensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult computer user | Experimental | Wearing each of the two spectacle lens designs for one month in random sequence Receives: Device: Spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in refractive status shift after one month of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Video Game Play Using Handheld ComputerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Responsible party
- Sponsor
- Investigators
- Chea-su Kee, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775396
- Sponsor's protocol ID
- P14-0085
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29683984
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearing a New Progressive Addition Lens on Working Distance and Refractive Status in Adult Chinese Computer Users
- ClinicalTrials.gov ID
- NCT02775396
- Acronym / sponsor ID
- P14-0085
- Conditions
- Video Game Play Using Handheld Computer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult computer user | Experimental | Device: Spectacle lensWearing each of the two spectacle lens designs for one month in random sequence |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hong Kong Chinese
- Computer users (computer usage >2hours/day)
- Spherical-equivalent refractive errors between plano and -9.00D and cylindrical power ≤2.50D
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectacle lensWearing 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. | Device | Adult computer user |
Primary outcome
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 29683984Kee 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chea-su Kee, PhD principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Spectacle lens in people with Video Game Play Using Handheld Computer, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in near working distance measured by an automatic ultrasound sensor (time frame: Change in near working distance after one month of lens wear). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.