Health TrialsbyHealthPanel

Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses

ConditionsMyopiaMyopia ProgressionJuvenile Myopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorSightGlass Vision, Inc.

About this trial

The aim of this study is evaluate and compare the mobility performance of children in daily activities while wearing single vision spectacle lenses (control) versus myopia control spectacle lenses (test).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Are between the ages of 6 and 12 years of age (inclusive) at the time of informed consent/assent.

Can achieve a corrected visual acuity of 20/20 best-corrected (or equivalent logMAR).

Have undergone a self-reported oculo-visual examination within the past two years.

Have no active ocular disease.

Disqualifiers

Have any systemic disease that affects ocular health.

Are currently using or have used, within the past 7 days, any systemic or topical medications that may impact ocular health.

Are currently using or have used any topical ophthalmic agents with anti-muscarinic properties within 7 days prior to enrollment or at any point during the study. This includes, but is not limited to, atropine, scopolamine, pirenzepine, tropicamide, cyclopentolate, and homatropine.

Have used any oral agents with anti-muscarinic properties for a chronic period (2 months or more) or short-term (within 7 days prior to enrollment). This includes, but is not limited to, gastrointestinal anti-spasmodic medications containing atropine, hyoscyamine, and dicyclomine.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Novel spectacle lens design

    Device

    Use of lenses may reduce the rate of progression of juvenile myopia

  • Spectacle lenses

    Device

    Use of lenses may reduce the rate of progression of juvenile myopia

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: SightGlass Vision Test Arm 1Experimental treatment 1 intervention
Group B: SightGlass Vision Test Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reaction time: the time elapsed between the appearance or activation of a visual stimulus and the initiation of the participant's physical response

Time frame
2 months
2

Movement time: the time taken to complete the motor response after it has been initiated.

Time frame
2 months
3

Response accuracy: the correctness of the participant's response to each visual stimulus, measured by the number or percentage of correctly identified or responded-to stimuli.

Time frame
2 months

Secondary outcomes

1

Gait cycle events, such as initial foot contact with the ground and toe-off. It will be used to assess whether the type of eyewear affects natural gait patterns or mobility during peripheral vision tasks.

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SightGlass Vision, Inc.

Lead sponsor

Source ClinicalTrials.gov
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