Visual AcuityNCT00366756
Evaluation of VisionQuest 20/20, a Visual Acuity Testing Software
An observational study of Visual Acuity, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study involves the use of VisionQuest 20/20 which is a new software program to test visual acuity in children. The purpose of this study is to compare the results of VisionQuest 20/20 to two other ways to measure visual acuity. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Nov 2008
- Phase
- Observational
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children ages 8-5 years with myopia.
Who may be able to join
- 8-15 years of age
- healthy volunteers
Who cannot join
- significant developmental delays or motor skill impairments which would prevent children from independently operating a computer mouse
- psychiatric disorders and/or attention deficit disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Evaluation of a Visual Acuity Testing Software for Children, VisionQuest 20/20
This study involves the use of VisionQuest 20/20 which is a new software program to test visual acuity in children. The purpose of this study is to compare the results of VisionQuest 20/20 to two other ways to measure visual acuity. The two other tests are a standard eye exam by an ophthalmologist and electronic visual acuity (EVA) testing, a computerized version of a standard eye test.
It is important to identify vision problems in children as early as possible. These problems include amblyopia ("lazy eye," or reduced vision due to lack of development in the visual area of the brain), strabismus (eyes are not aligned correctly due to eye muscle problems), and refractive errors (when you need glasses to see up close or far away). Early identification of the vision problems allows them to be treated earlier which makes it more likely that vision can be improved. VisionQuest 20/20 can be easily distributed to schools, and it is easy for the child and the vision screener to use. The test can be performed by volunteers instead of an ophthalmologist.
Read the detailed description
Assessing visual acuity represents one of the most sensitive techniques for the detection of eye abnormalities in children. Vision disorders are the fourth most common disability in the USA and are the most prevalent handicapping condition in childhood. Ocular conditions, if undetected or untreated, can have substantial long-term implications for the quality of life of the child and the family and can place a burden on public health resources.
Important causes of visual impairment in children include amblyopia, strabismus and significant refractive error. Children with these conditions may benefit from early detection to allow treatment. Early detection and treatment is the key for successful management of children with visual disorders. If detected during childhood, treatment for amblyopia is effective and inexpensive. Although amblyopia is a treatable disorder if detected in childhood during the brain's "critical period" for vision development, every year the problem goes undetected and untreated in thousands of US children resulting in permanent visual disability for the individuals and hundreds of millions of dollars of annual economic loss to society. Furthermore, other less serious types of childhood vision problems, such as refractive errors, may contribute to academic underperformance if not identified during childhood. What ages, venues, and methodologies are best to perform vision screenings and when full eye examinations are indicated remains to be determined. , Nevertheless, nearly universal agreement exists among U.S. government agencies, health experts, educators, and charitable vision organizations that children should be screened for visual disorders, even if asymptomatic. To date, a combination of scientific, logistical, economic, and legislative shortcomings have prevented vision screening goals from being met for many U.S. children.
The ideal vision screening method should be accurate (sensitive and specific for clinically significant visual problems amenable to treatment), standardized, easy to administer and interpret with little training, cost effective, universally available to children, and capable of collecting data to ensure medical follow-up is received by those who need it as well as to collect epidemiological information and monitor the success of the program year after year. The Amblyopia Foundation of America (AFA) has conceptualized how automated computer software which assesses vision while a child "plays" a video game could potentially meet the requirements for an ideal vision screening system for children old enough to cooperate.
Young children are increasingly familiar with computers and videogames, oftentimes being more sophisticated in their use than their parents. Vision screening software is easy to distribute via CDs or the internet. Computers are readily available in virtually all schools and the cost of computer technology continues to decline even as performance improves. Computer software applications allow standardization of logic protocols for vision screenings and the videogame format allow for automated testing. Automated testing eliminates the need for large scale training and certification of vision screening proctors and instead can allow vision screenings to be performed by untrained lay volunteers or personnel already available in schools. Finally, since responses of children being tested are inputted directly into the computer, results may be printed instantaneously at the end of testing. Computer data may be warehoused locally or offsite via the internet to help coordinate medical follow-up for those children identified at risk, monitor the success of the program, and facilitate epidemiological analysis of vision disorders. Prototype VisionQuest 20/20 software currently performs standardized visual acuity assessments of each eye and stereopsis testing while a child "plays" a 2-3 minute video game.
A pilot study (O'Neil J.W., et al 2005 unpublished) suggested lay screeners using this an early version of this prototype vision screening software on laptop computers achieved similar positive and negative predictive value results to a certified ophthalmic technician using a professional grade M\&S vision tester. Positive predictive values for clinically significant visual disorders were 54% for M\&S and 52% for VisionQuest 20/20 respectively. Negative predictive values were identical at 97% for each screening method. VisionQuest 20/20 appears to have potential for use as a vision screener for schoolchildren and may allow more children to be reached than manual vision screening or other methods by relying on lay personnel already available in schools rather than certified vision screeners or eye professionals to perform screenings. Additional benefits include use of computers already available in schools with the potential to simplify vision screening logistics and reduce costs. Independent validity testing is essential before initiating large scale community vision screenings with this new vision screening software. The primary aim of the current study is to validate VisionQuest 20/20 screening software by assessing its ability to screen for threshold visual acuities as compared to an exact visual acuity obtained with the EVA tester using ETDRS optotypes. The secondary aim of the current study is to evaluate the ability of VisionQuest 20/20 software to detect the presence or absence of clinically significant vision disorders in children as compared to a professional eye examination by a pediatric ophthalmologist.
- Conditions
- Visual Acuity
- Keywords
- Vision, Visual Acuity
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Eye Test
This study involves the use of VisionQuest 20/20 which is a new software program to test visual acuity in children. The purpose of this study is to compare the results of VisionQuest 20/20 to two other ways to measure visual acuity. The two other tests are a standard eye exam by an ophthalmologist and electronic visual acuity (EVA) testing, a computerized version of a standard eye test.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Marion E. Wilson, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366756
- Sponsor's protocol ID
- SEI-06-001
- Status last verified
- Dec 2010
- First submitted
- 17 Aug 2006
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Visual Acuity Testing Software for Children, VisionQuest 20/20
- ClinicalTrials.gov ID
- NCT00366756
- Acronym / sponsor ID
- SEI-06-001
- Conditions
- Visual Acuity
- Keywords
- Vision, Visual Acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Aug 2006 (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.
This study involves the use of VisionQuest 20/20 which is a new software program to test visual acuity in children. The purpose of this study is to compare the results of VisionQuest 20/20 to two other ways to measure visual acuity. The two other tests are a standard eye exam by an ophthalmologist and electronic visual acuity (EVA) testing, a computerized version of a standard eye test.
It is important to identify vision problems in children as early as possible. These problems include amblyopia ("lazy eye," or reduced vision due to lack of development in the visual area of the brain), strabismus (eyes are not aligned correctly due to eye muscle problems), and refractive errors (when you need glasses to see up close or far away). Early identification of the vision problems allows them to be treated earlier which makes it more likely that vision can be improved. VisionQuest 20/20 can be easily distributed to schools, and it is easy for the child and the vision screener to use. The test can be performed by volunteers instead of an ophthalmologist.
Detailed description
Assessing visual acuity represents one of the most sensitive techniques for the detection of eye abnormalities in children. Vision disorders are the fourth most common disability in the USA and are the most prevalent handicapping condition in childhood. Ocular conditions, if undetected or untreated, can have substantial long-term implications for the quality of life of the child and the family and can place a burden on public health resources.
Important causes of visual impairment in children include amblyopia, strabismus and significant refractive error. Children with these conditions may benefit from early detection to allow treatment. Early detection and treatment is the key for successful management of children with visual disorders. If detected during childhood, treatment for amblyopia is effective and inexpensive. Although amblyopia is a treatable disorder if detected in childhood during the brain's "critical period" for vision development, every year the problem goes undetected and untreated in thousands of US children resulting in permanent visual disability for the individuals and hundreds of millions of dollars of annual economic loss to society. Furthermore, other less serious types of childhood vision problems, such as refractive errors, may contribute to academic underperformance if not identified during childhood. What ages, venues, and methodologies are best to perform vision screenings and when full eye examinations are indicated remains to be determined. , Nevertheless, nearly universal agreement exists among U.S. government agencies, health experts, educators, and charitable vision organizations that children should be screened for visual disorders, even if asymptomatic. To date, a combination of scientific, logistical, economic, and legislative shortcomings have prevented vision screening goals from being met for many U.S. children.
The ideal vision screening method should be accurate (sensitive and specific for clinically significant visual problems amenable to treatment), standardized, easy to administer and interpret with little training, cost effective, universally available to children, and capable of collecting data to ensure medical follow-up is received by those who need it as well as to collect epidemiological information and monitor the success of the program year after year. The Amblyopia Foundation of America (AFA) has conceptualized how automated computer software which assesses vision while a child "plays" a video game could potentially meet the requirements for an ideal vision screening system for children old enough to cooperate.
Young children are increasingly familiar with computers and videogames, oftentimes being more sophisticated in their use than their parents. Vision screening software is easy to distribute via CDs or the internet. Computers are readily available in virtually all schools and the cost of computer technology continues to decline even as performance improves. Computer software applications allow standardization of logic protocols for vision screenings and the videogame format allow for automated testing. Automated testing eliminates the need for large scale training and certification of vision screening proctors and instead can allow vision screenings to be performed by untrained lay volunteers or personnel already available in schools. Finally, since responses of children being tested are inputted directly into the computer, results may be printed instantaneously at the end of testing. Computer data may be warehoused locally or offsite via the internet to help coordinate medical follow-up for those children identified at risk, monitor the success of the program, and facilitate epidemiological analysis of vision disorders. Prototype VisionQuest 20/20 software currently performs standardized visual acuity assessments of each eye and stereopsis testing while a child "plays" a 2-3 minute video game.
A pilot study (O'Neil J.W., et al 2005 unpublished) suggested lay screeners using this an early version of this prototype vision screening software on laptop computers achieved similar positive and negative predictive value results to a certified ophthalmic technician using a professional grade M\&S vision tester. Positive predictive values for clinically significant visual disorders were 54% for M\&S and 52% for VisionQuest 20/20 respectively. Negative predictive values were identical at 97% for each screening method. VisionQuest 20/20 appears to have potential for use as a vision screener for schoolchildren and may allow more children to be reached than manual vision screening or other methods by relying on lay personnel already available in schools rather than certified vision screeners or eye professionals to perform screenings. Additional benefits include use of computers already available in schools with the potential to simplify vision screening logistics and reduce costs. Independent validity testing is essential before initiating large scale community vision screenings with this new vision screening software. The primary aim of the current study is to validate VisionQuest 20/20 screening software by assessing its ability to screen for threshold visual acuities as compared to an exact visual acuity obtained with the EVA tester using ETDRS optotypes. The secondary aim of the current study is to evaluate the ability of VisionQuest 20/20 software to detect the presence or absence of clinically significant vision disorders in children as compared to a professional eye examination by a pediatric ophthalmologist.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children ages 8-5 years with myopia.
Key inclusion criteria (2 listed)
- 8-15 years of age
- healthy volunteers
Key exclusion criteria (2 listed)
- significant developmental delays or motor skill impairments which would prevent children from independently operating a computer mouse
- psychiatric disorders and/or attention deficit disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standard Eye Test
Time frame: 12 Months
This study involves the use of VisionQuest 20/20 which is a new software program to test visual acuity in children. The purpose of this study is to compare the results of VisionQuest 20/20 to two other ways to measure visual acuity. The two other tests are a standard eye exam by an ophthalmologist and electronic visual acuity (EVA) testing, a computerized version of a standard eye test.
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 5 Aug 2011.
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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.
Marion E. Wilson, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity, run by Medical University of South Carolina at 1 site in United States.
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 2 inclusion and 2 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 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Standard Eye Test (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2011.