Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

ConditionsAnisometropia Hyperopia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-12

SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

To evaluate the effectiveness of light-blocking lenses in promoting emmetropization and reducing anisometropia in children with hyperopic anisometropia, and to assess the impact of light-intercepting lenses on visual function in this population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 6 years or older and 12 years or younger;

The more hyperopic eye has a spherical refractive error between +3.0 D and +7.5 D; the less hyperopic eye has a spherical refractive error of at least +2.0 D; cylindrical refractive error between -2.0 D and 0 D; interocular difference in spherical power >=1.5 D and in cylindrical power <=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
The eye with higher hyperopia will be fitted with light-blocking lenses for full-time wear, while the fellow eye with lower hyperopia will be fitted with conventional single-vision lenses for full-time wear, over 12 months
single-vision lenses
Other intervention
Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Intervention GroupExperimental treatment 1 intervention

Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes