AccommodationNCT05684224
Assessing Dynamic Reading Behaviors Using Eye-Tracking Tobii Glasses
An observational study of Accommodation, run by State University of New York College of Optometry at 1 site in United States.
Trial summary
HYPOTHESIS: 1. Horizontal convergence tracked with Tobii glasses is a reliable substitute for accommodation in young myopes and hyperopes with normal accommodative amplitudes 2. Young mypopes and hyperopes demonstrate different reading behaviors during near work AIMS \& OBJECTIVES: 1. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Accommodation
- What is being tested?
- Dynamic accommodation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2022to 31 Dec 2024
- 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 18 to 30 years
- All sexes
- Adult
Study population: Young adults between 18 and 30 years of age. Subjects will be recruited from students at SUNY College of Optometry.
Who may be able to join
- Age: Subjects who are 18 to 30 years old
- Refractive error: Subjects with myopia between -1.00 and -5.00 D in each eye (n = 5), or hyperopia between +2.00 and +5.00 D in each eye (n = 5), determined by spherical equivalent using dry manifest refraction and binocular balance
- Astigmatism <= 0.75 D in each eye
- Anisometropia <= 1.50 D
- BCVA at distance 20/20 in each eye
- Habitual contact lens wears or willing to wear single vision and multifocal contact lenses during the 2nd study visit
- Normal eye posture and accommodation
- Good general and ocular health
Who cannot join
- Strabismus at distance or near
- Amblyopia
- Significant anisometropia (>1.50 D)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Xiaoying Zhu
New York, New York, 10036
Xiaoying Zhu, OD, PhD, MD, MS, FAAO, 2129385541, xzhu@sunyopt.edu
Robert McPeek, PhD, 212-938-5762, rmcpeek@sunyopt.edu
About this study
HYPOTHESIS:
- Horizontal convergence tracked with Tobii glasses is a reliable substitute for accommodation in young myopes and hyperopes with normal accommodative amplitudes
- Young mypopes and hyperopes demonstrate different reading behaviors during near work
Read more
AIMS \& OBJECTIVES:
- Compare the accommodative responses measured with the Grand Seiko open-field autorefractor to those derived from the Tobii Glasses, when subjects wear (1) spectacle glasses, (2) single vision contact lenses (SVCLs), and (3) multifocal contact lenses (MFCLs).
- Investigate subjects' natural and dynamic accommodative behaviors and eye postures during reading using the Tobii Glasses.
- Compare the change in natural and dynamic accommodative behaviors and eye postures during reading between myopes and hyperopes using the Tobii Glasses.
Read the detailed description
Excessive axial elongation underlying myopia development and progression predisposes the eye to various sight-threatening complications including myopic maculopathy, retinal detachment, and glaucoma. The persistent and progressive nature of the myopic axial elongation results in the cumulative lifetime risk of developing irreversible low vision or blindness to increase exponentially with increasing myopia severity. With rapidly increasing worldwide prevalence, myopia has become a leading cause of visual impairment and blindness. Preventing myopia progression in childhood is therefore critical. Rapid increases in myopia prevalence in recent decades highlight the significant impact of environmental factors on myopia development and progression, as change in gene pools cannot account for the dramatic change. There is a growing body of evidence of the protective effect of increased time outdoors against myopia onset and progression. Increased time outdoors has also been shown to reduce the impact of parental myopia as a risk factor for childhood myopia. A school-based intervention study that encouraged Taiwanese primary school children to spend 120 minutes outdoors each day demonstrated less reduced visual acuity, a surrogate measure of myopia, highlighting the benefits of increased time outdoors on myopia. This has prompted initiatives worldwide to encourage children to spend more time outside. Another key risk factor for myopia is near work. A recent meta-analysis reported greater time on near work to be associated with higher odds of myopia. Greater near work in the form of reading and writing are thought to be the underlying causal link between education and myopia. Studies have found that children with higher academic performance or who attend more academically orientated classes or schools tend to be more myopic. Students using near work distances shorter than 30 cm and for periods greater than 30 minutes experienced greater myopia progression after only 6-months. Screen time, often considered a surrogate of near work, has also been associated to the increased prevalence of myopia. Despite recognition of these key environmental and behavioral risk factors for myopia, guidelines on appropriate risk management in children undergoing myopia control treatments are minimal due to lack of robust evidence.
Various optical and pharmacological interventions have been developed to prevent the progression of childhood myopia, including specially-designed spectacles, multifocal contact lenses, orthokeratology, and low concentration atropine eye drops. However, no treatment is 100% effective; 20% of myopic children on treatment progress as if they were not being treated, and more than 50% of treated children still demonstrate significant progression. Accurate quantification of the visual environment and behavior of myopic children and the impact on treatment efficacy will guide clinicians on risk management and improve responses to existing treatments for progressive myopia. Multifocal soft contact lens (MFCL) with central distance correction and a peripheral plus power profile is an effective treatment strategy for myopia control in children, with variable efficacies. One possible explanation is that children wearing these lenses under-accommodate at near which could reduce the lenses' treatment effect. It would be important to track the dynamic reading behaviors to better understand how accommodation and other binocular functions may change during reading. As of now, no portal devices can track dynamic accommodation. Tobii glasses are wearable eye trackers that accurately record horizontal and vertical vergences, pupil size, and reading distance over time. Investigator's pilot data shows that horizontal convergence can be used as a substitute for accommodation in subjects with normal accommodative amplitudes and eye posture. This study aims to compare the accuracy of accommodative measurements obtained with the Grand Seiko open-field autorefractor and the Tobii Glasses, when subjects wear (1) spectacle glasses, (2) single vision contact lenses (SVCLs), and (3) MFCLs. This study will also track the subject's natural reading behavior.
- Conditions
- Accommodation
- Being tested
- Dynamic accommodation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic accommodationBehavioural
Dynamic accommodation will be tracked using the Tobii Glasses
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal convergence
Horizontal convergence will be tracked using the Tobii Glasses
Measured: Horizontal convergence during reading will be measured using the Tobii Glasses continuously for 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start14 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccommodationStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoying Zhu, OD, PhD, MD, MS, FAAO, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684224
- Sponsor's protocol ID
- IRBNET.ORG 1921452
- Status last verified
- Mar 2024
- First submitted
- 1 Jan 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Dynamic Reading Behaviors Using Eye-Tracking Tobii Glasses
- ClinicalTrials.gov ID
- NCT05684224
- Acronym / sponsor ID
- IRBNET.ORG 1921452
- Conditions
- Accommodation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Jan 2023 (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.
HYPOTHESIS:
- Horizontal convergence tracked with Tobii glasses is a reliable substitute for accommodation in young myopes and hyperopes with normal accommodative amplitudes
- Young mypopes and hyperopes demonstrate different reading behaviors during near work
AIMS \& OBJECTIVES:
- Compare the accommodative responses measured with the Grand Seiko open-field autorefractor to those derived from the Tobii Glasses, when subjects wear (1) spectacle glasses, (2) single vision contact lenses (SVCLs), and (3) multifocal contact lenses (MFCLs).
- Investigate subjects' natural and dynamic accommodative behaviors and eye postures during reading using the Tobii Glasses.
- Compare the change in natural and dynamic accommodative behaviors and eye postures during reading between myopes and hyperopes using the Tobii Glasses.
Detailed description
Excessive axial elongation underlying myopia development and progression predisposes the eye to various sight-threatening complications including myopic maculopathy, retinal detachment, and glaucoma. The persistent and progressive nature of the myopic axial elongation results in the cumulative lifetime risk of developing irreversible low vision or blindness to increase exponentially with increasing myopia severity. With rapidly increasing worldwide prevalence, myopia has become a leading cause of visual impairment and blindness. Preventing myopia progression in childhood is therefore critical. Rapid increases in myopia prevalence in recent decades highlight the significant impact of environmental factors on myopia development and progression, as change in gene pools cannot account for the dramatic change. There is a growing body of evidence of the protective effect of increased time outdoors against myopia onset and progression. Increased time outdoors has also been shown to reduce the impact of parental myopia as a risk factor for childhood myopia. A school-based intervention study that encouraged Taiwanese primary school children to spend 120 minutes outdoors each day demonstrated less reduced visual acuity, a surrogate measure of myopia, highlighting the benefits of increased time outdoors on myopia. This has prompted initiatives worldwide to encourage children to spend more time outside. Another key risk factor for myopia is near work. A recent meta-analysis reported greater time on near work to be associated with higher odds of myopia. Greater near work in the form of reading and writing are thought to be the underlying causal link between education and myopia. Studies have found that children with higher academic performance or who attend more academically orientated classes or schools tend to be more myopic. Students using near work distances shorter than 30 cm and for periods greater than 30 minutes experienced greater myopia progression after only 6-months. Screen time, often considered a surrogate of near work, has also been associated to the increased prevalence of myopia. Despite recognition of these key environmental and behavioral risk factors for myopia, guidelines on appropriate risk management in children undergoing myopia control treatments are minimal due to lack of robust evidence.
Various optical and pharmacological interventions have been developed to prevent the progression of childhood myopia, including specially-designed spectacles, multifocal contact lenses, orthokeratology, and low concentration atropine eye drops. However, no treatment is 100% effective; 20% of myopic children on treatment progress as if they were not being treated, and more than 50% of treated children still demonstrate significant progression. Accurate quantification of the visual environment and behavior of myopic children and the impact on treatment efficacy will guide clinicians on risk management and improve responses to existing treatments for progressive myopia. Multifocal soft contact lens (MFCL) with central distance correction and a peripheral plus power profile is an effective treatment strategy for myopia control in children, with variable efficacies. One possible explanation is that children wearing these lenses under-accommodate at near which could reduce the lenses' treatment effect. It would be important to track the dynamic reading behaviors to better understand how accommodation and other binocular functions may change during reading. As of now, no portal devices can track dynamic accommodation. Tobii glasses are wearable eye trackers that accurately record horizontal and vertical vergences, pupil size, and reading distance over time. Investigator's pilot data shows that horizontal convergence can be used as a substitute for accommodation in subjects with normal accommodative amplitudes and eye posture. This study aims to compare the accuracy of accommodative measurements obtained with the Grand Seiko open-field autorefractor and the Tobii Glasses, when subjects wear (1) spectacle glasses, (2) single vision contact lenses (SVCLs), and (3) MFCLs. This study will also track the subject's natural reading behavior.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Young adults between 18 and 30 years of age. Subjects will be recruited from students at SUNY College of Optometry.
Key inclusion criteria (8 listed)
- Age: Subjects who are 18 to 30 years old
- Refractive error: Subjects with myopia between -1.00 and -5.00 D in each eye (n = 5), or hyperopia between +2.00 and +5.00 D in each eye (n = 5), determined by spherical equivalent using dry manifest refraction and binocular balance
- Astigmatism <= 0.75 D in each eye
- Anisometropia <= 1.50 D
- BCVA at distance 20/20 in each eye
Key exclusion criteria (3 listed)
- Strabismus at distance or near
- Amblyopia
- Significant anisometropia (>1.50 D)
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 |
|---|---|---|
| Dynamic accommodationDynamic accommodation will be tracked using the Tobii Glasses | Behavioural | – |
Primary outcome
Horizontal convergence
Time frame: Horizontal convergence during reading will be measured using the Tobii Glasses continuously for 5 minutes
Horizontal convergence will be tracked using the Tobii Glasses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Accommodation, run by State University of New York College of Optometry 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Zhu, OD, PhD, MD, MS, FAAO (2129385541, xzhu@sunyopt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal convergence (time frame: Horizontal convergence during reading will be measured using the Tobii Glasses continuously for 5 minutes). 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 22 Mar 2024.