AmblyopiaNCT04321538
Gocheck Kids vs. Welch Allyn Spot Vision Screener
An observational study of Amblyopia, run by Yale University at 1 site in United States.
Trial summary
The investigators are conducting a prospective evaluation of the ability of two vision photoscreening devices (GoCheck Kids and the Welch Allyn Spot Vision Screener) to detect risk factors for amblyopia. Photoscreeners function similar to having a picture taken with a camera. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Gocheck Kids, Welch Allyn Spot Vision Screener and Physical Exam
- Type of treatment
- Medical device
- How many people
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 19 Dec 2022
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ages 1-<7 years referred to a Yale New Haven Hospital and Yale Medicine associated pediatric ophthalmology practice for a failed vision screen.
Who may be able to join
- Children ages 1-<7 years.
Who cannot join
- Children with a history of ocular surgery and children with ocular conditions or behavior that preclude obtainment of the screening photo images or completion of a complete eye exam.
- Children with an obstructed visual axis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Evaluation of the GoCheck Kids Mobile Vision Screening Application and the Welch Allyn Spot Vision Screener
The investigators are conducting a prospective evaluation of the ability of two vision photoscreening devices (GoCheck Kids and the Welch Allyn Spot Vision Screener) to detect risk factors for amblyopia. Photoscreeners function similar to having a picture taken with a camera. Amblyopia is decreased vision in one or both eyes due to decreased vision development in the brain resulting from decreased visual stimulation. Children ages 1 year to less than 7 years of age referred to a pediatric ophthalmologist at Yale New Haven Health and Yale Medicine locations for a failed vision screen will be offered participation. The ability of each screening device to detect amblyopia risk factors will be compared with the results of a complete eye exam performed by the practitioner.
Read the detailed description
The United States Preventive Services Task Force has recommended early screening in children in order to detect vision abnormalities that could result in amblyopia, a condition in which there is abnormal brain development when there is suboptimal vision in one or both eyes. Prior to the introduction of vision screening instruments, physicians would wait to screen children at age 3-4, when they are able to read letter or symbol charts. The introduction of vision screening instruments has provided a screening option for children as young as 6 months.
Photoscreening devices evaluate for amblyopia risk factors, including refractive error (need for glasses), or strabismus (eye misalignment). Since the advent of instrumental vision screening, improvements are continually being made to improve the quality and scope of vision screening devices. As more affordable and convenient instruments are developed to supplement the traditional letter charts used to screen children, there is a need for more prospective trials to test the efficacy of these instruments. Our study is designed to evaluate the latest model of GoCheck Kids iPhone vision screener with the widely-used Welch Allyn Spot Vision Screener. The GoCheck Kids smartphone application is paid for on a monthly basis and includes telephone rental rather than requiring that a device be purchased. This lower upfront cost option will allow for more primary care practices to participate with a decreased upfront financial burden.
Children ages 1 year to less than 7 years referred to a Yale New Haven Hospital and Yale Medicine pediatric ophthalmology practice for a failed vision screen will be prospectively recruited for participation at the time of their already scheduled appointment for a complete eye exam. Following informed consent, each participant will be screened using both the GoCheck Kids smartphone application and the Welch Allyn Spot Vision Screener. Screening for each of these devices involves a process akin to having a photograph taken. Obtaining consent and photo screenings will take less than 5 minutes. The complete eye exam, which will be performed in this referral group regardless of study participation, will include evaluation of the front and back of the eye, eye alignment, and determination of the refractive state by retinoscopy (check if glasses are needed by using a special type of light and handheld lenses). The ability of each screening device to detect amblyopia risk factors when they are present (sensitivity) will be determined by comparison with the detection of amblyopia risk factors during the complete eye exam, which is considered the gold standard.
- Conditions
- Amblyopia
- Being tested
- Gocheck Kids, Welch Allyn Spot Vision Screener, Physical Exam
- Keywords
- GoCheck Kids, Welch Allyn Spot Vision Screener, Vision Screening, Photoscreening
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gocheck KidsDevice
GoCheck Kids is a photoscreening device. It takes a special picture of the eyes that allows for detection of refractive error and eye misalignment.
Welch Allyn Spot Vision ScreenerDevice
The Welch Allyn Spot Vision Screener is a photoscreening device. It takes a special picture of the eyes that allows for the detection of refractive error and eye misalignment.
Physical ExamDiagnostic test
Retinoscopy and an oculomotor testing will constitute the physical examination.
| Study group | Role | What they receive |
|---|---|---|
| Failed Vision Screen Cohort | This cohort represents the entire group of study participants- children who were referred to Yale New Haven Hospital and Yale Medicine for a failed vision screen by either their primary care provider or their school. Receives: Device: Gocheck Kids; Device: Welch Allyn Spot Vision Screener; Diagnostic Test: Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivities for amblyopia risk factor detection
The sensitivity is the percentage of patients with amblyopia whose vision screen indicates they have an amblyopia risk factor. The sensitivity for the detection of amblyopia risk factors is determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens by the photoscreener (as determined by the gold standard physical exam including cycloplegic retinoscopy to look for refractive error and oculomotor exam to evaluate strabismus) and dividing by the sum of truly positive failed vision screens plus false-negative vision screens (the vision screener did not detect amblyopia risk factors when they were found to be present on the physical exam).
Measured: Up to 2 hours
Secondary outcomes (2)
Sensitivity for detection of refractive error
The refractive error will be determined using the gold standard physical exam technique of cycloplegic retinoscopy. The sensitivity for the detection of refractive error will be determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens for refractive error and dividing by the sum of truly positive failed vision screens for refractive error plus false-negative vision screens for refractive error.
Measured: Up to 2 hours
Sensitivity for detection of strabismus
The presence of strabismus will be determined using an oculomolotor exam. The sensitivity for the detection of strabismus will be determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens for strabismus and dividing by the sum of truly positive failed vision screens for strabismus plus false-negative vision screens for strabismus.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Feb 2021
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
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 AmblyopiaStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha A Howard, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321538
- Sponsor's protocol ID
- 2000026666
- Status last verified
- Feb 2023
- First submitted
- 24 Mar 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan on sharing protected health information with other researchers.
Publications
US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Vision Screening in Children Aged 6 Months to 5 Years: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Sep 5;318(9):836-844. doi: 10.1001/jama.2017.11260.
PubMed 28873168
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GoCheck Kids Mobile Vision Screening Application and the Welch Allyn Spot Vision Screener
- ClinicalTrials.gov ID
- NCT04321538
- Acronym / sponsor ID
- 2000026666
- Conditions
- Amblyopia
- Keywords
- GoCheck Kids, Welch Allyn Spot Vision Screener, Vision Screening, Photoscreening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 25 Mar 2020 (actual)
- 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.
The investigators are conducting a prospective evaluation of the ability of two vision photoscreening devices (GoCheck Kids and the Welch Allyn Spot Vision Screener) to detect risk factors for amblyopia. Photoscreeners function similar to having a picture taken with a camera. Amblyopia is decreased vision in one or both eyes due to decreased vision development in the brain resulting from decreased visual stimulation. Children ages 1 year to less than 7 years of age referred to a pediatric ophthalmologist at Yale New Haven Health and Yale Medicine locations for a failed vision screen will be offered participation. The ability of each screening device to detect amblyopia risk factors will be compared with the results of a complete eye exam performed by the practitioner.
Detailed description
The United States Preventive Services Task Force has recommended early screening in children in order to detect vision abnormalities that could result in amblyopia, a condition in which there is abnormal brain development when there is suboptimal vision in one or both eyes. Prior to the introduction of vision screening instruments, physicians would wait to screen children at age 3-4, when they are able to read letter or symbol charts. The introduction of vision screening instruments has provided a screening option for children as young as 6 months.
Photoscreening devices evaluate for amblyopia risk factors, including refractive error (need for glasses), or strabismus (eye misalignment). Since the advent of instrumental vision screening, improvements are continually being made to improve the quality and scope of vision screening devices. As more affordable and convenient instruments are developed to supplement the traditional letter charts used to screen children, there is a need for more prospective trials to test the efficacy of these instruments. Our study is designed to evaluate the latest model of GoCheck Kids iPhone vision screener with the widely-used Welch Allyn Spot Vision Screener. The GoCheck Kids smartphone application is paid for on a monthly basis and includes telephone rental rather than requiring that a device be purchased. This lower upfront cost option will allow for more primary care practices to participate with a decreased upfront financial burden.
Children ages 1 year to less than 7 years referred to a Yale New Haven Hospital and Yale Medicine pediatric ophthalmology practice for a failed vision screen will be prospectively recruited for participation at the time of their already scheduled appointment for a complete eye exam. Following informed consent, each participant will be screened using both the GoCheck Kids smartphone application and the Welch Allyn Spot Vision Screener. Screening for each of these devices involves a process akin to having a photograph taken. Obtaining consent and photo screenings will take less than 5 minutes. The complete eye exam, which will be performed in this referral group regardless of study participation, will include evaluation of the front and back of the eye, eye alignment, and determination of the refractive state by retinoscopy (check if glasses are needed by using a special type of light and handheld lenses). The ability of each screening device to detect amblyopia risk factors when they are present (sensitivity) will be determined by comparison with the detection of amblyopia risk factors during the complete eye exam, which is considered the gold standard.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Failed Vision Screen Cohort | – | Device: Gocheck Kids, Device: Welch Allyn Spot Vision Screener, Diagnostic Test: Physical ExamThis cohort represents the entire group of study participants- children who were referred to Yale New Haven Hospital and Yale Medicine for a failed vision screen by either their primary care provider or their school. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ages 1-<7 years referred to a Yale New Haven Hospital and Yale Medicine associated pediatric ophthalmology practice for a failed vision screen.
Key inclusion criteria (1 listed)
- Children ages 1-<7 years.
Key exclusion criteria (2 listed)
- Children with a history of ocular surgery and children with ocular conditions or behavior that preclude obtainment of the screening photo images or completion of a complete eye exam.
- Children with an obstructed visual axis.
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 |
|---|---|---|
| Gocheck KidsGoCheck Kids is a photoscreening device. It takes a special picture of the eyes that allows for detection of refractive error and eye misalignment. | Device | Failed Vision Screen Cohort |
| Welch Allyn Spot Vision ScreenerThe Welch Allyn Spot Vision Screener is a photoscreening device. It takes a special picture of the eyes that allows for the detection of refractive error and eye misalignment. | Device | Failed Vision Screen Cohort |
| Physical ExamRetinoscopy and an oculomotor testing will constitute the physical examination. | Diagnostic test | Failed Vision Screen Cohort |
Primary outcome
Sensitivities for amblyopia risk factor detection
Time frame: Up to 2 hours
The sensitivity is the percentage of patients with amblyopia whose vision screen indicates they have an amblyopia risk factor. The sensitivity for the detection of amblyopia risk factors is determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens by the photoscreener (as determined by the gold standard physical exam including cycloplegic retinoscopy to look for refractive error and oculomotor exam to evaluate strabismus) and dividing by the sum of truly positive failed vision screens plus false-negative vision screens (the vision screener did not detect amblyopia risk factors when they were found to be present on the physical exam).
2 secondary outcomes
Sensitivity for detection of refractive error
Time frame: Up to 2 hours
Sensitivity for detection of strabismus
Time frame: Up to 2 hours
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 1 Mar 2023.
- Background: PubMed 28873168US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Vision Screening in Children Aged 6 Months to 5 Years: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Sep 5;318(9):836-844. doi: 10.1001/jama.2017.11260.
- Individual participant dataSharing planned: No. The investigators do not plan on sharing protected health information with other researchers.
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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.
Martha A Howard, MD principal investigator
Yale University
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 Amblyopia, run by Yale University 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 1 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 1 Mar 2023. 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?
Sensitivities for amblyopia risk factor detection (time frame: Up to 2 hours). 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 NCT04321538, 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 1 Mar 2023.