Recruiting NCT07229365
Children's Viewing Behavior
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novel spectacle lens design, Spectacle lenses.
- Who it may be relevant to
- Registry conditions: Myopia, Myopia Progression, Juvenile Myopia. Basic parameters: 7 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Children's Viewing Behavior in Myopia Control Spectacles
Overview
The aim of this study is to investigate the area of the spectacle lens in which a subject is viewing through regardless of task being performed.
Interventions
- Device Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia - Device Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia
Primary outcome measures
- Activity dependent, gaze location in myopia control spectacles [Time frame: 2 months]
- Subjective/objective quantification of activity via survey or observation [Time frame: 2 months]
- Pupil size [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
A person is eligible for inclusion in the study if he/she:
- Is 7-14 years of age, inclusive
- Requires spherical spectacle lenses within the power range available for the study lenses
- Parent/guardian has read and understood the informed consent form, and the child has provided age-appropriate assent
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best corrected
- Has had a self-reported oculo-visual examination in the last two years
- Spectacle cylinder of ≤ -0.75DC in both eyes
Exclusion criteria
A person will be excluded from the study if he/she:
- Is unable to complete the necessary study activities
- Has any systemic disease affecting ocular health
- Is using any systemic or topical medications (including pharmaceutical myopia control therapy) that will affect ocular health
- Is aphakic
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Indiana University — Bloomington
Identifiers
NCT: NCT07229365 · CPRO-2507-002