Effect of Light-Blocking Lenses on Pediatric Hyperopia

ConditionHyperopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

This study aims to assess the efficacy of light-blocking lenses in facilitating emmetropization in children with hyperopia and to explore their influence on various aspects of visual function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 6 years or older and 12 years or younger;

Spherical refractive error in both eyes between +3.0 D and +7.5 D, cylindrical refractive error between -2.0 D and 0 D; interocular difference in spherical power less than 1.5 D and in cylindrical power no greater than 1.0 D;

Best-corrected visual acuity of 0.0 logMAR or better in both eyes;

Ocular deviation with spectacles less than 10 prism diopters;

Disqualifiers

History of ocular trauma or eye surgery;

Presence of pathological abnormalities on anterior or posterior segment examination, or a history of organic ocular diseases such as cataract, glaucoma, corneal disease, or fundus disorders;

Intraocular pressure greater than 21 mmHg;

Presence of systemic diseases or other conditions deemed unsuitable for study participation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • light-blocking lenses

    Other intervention

    Subjects will be instructed to wear light-blocking lenses full-time for 12 months.

  • single-vision lenses

    Other intervention

    Subjects will be instructed to wear single-vision lenses full-time for 12 months.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Axial length

measured by optical biometer

Time frame
At baseline, 6 months, and 12 months

Secondary outcomes

1

Refractive error

measured by cycloplegic refraction

Time frame
At baseline, 6 months, and 12 months
2

Best-corrected visual acuity

measured by visual acuity chart

Time frame
At baseline, 6 months, and 12 months
3

Intraocular pressure

measured by non-contact tonometer

Time frame
At baseline, 6 months, and 12 months
4

Angle of deviation

measured by alternate cover test with prism

Time frame
At baseline, 6 months, and 12 months

Other outcomes

1

Height

measured by ruler

Time frame
At baseline, 6 months, and 12 months
2

Weight

measured by weighing scale

Time frame
At baseline, 6 months, and 12 months
3

Choroidal thickness (optional)

measured by OCT, optional

Time frame
At baseline, 6 months, and 12 months

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: