Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05684224 |
| Other study ID # |
IRBNET.ORG 1921452 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 14, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
State University of New York College of Optometry |
| Contact |
Xiaoying Zhu, OD, PhD, MD, MS, FAAO |
| Phone |
2129385541 |
| Email |
xzhu[@]sunyopt.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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).
2. Investigate subjects' natural and dynamic accommodative behaviors and eye postures
during reading using the Tobii Glasses.
3. Compare the change in natural and dynamic accommodative behaviors and eye postures
during reading between myopes and hyperopes using the Tobii Glasses.
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.
