Anisometropia, Hyperopia
Conditions
Keywords
Anisometropia, Hyperopia, light-blocking lenses, emmetropization
Brief summary
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.
Interventions
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
OTHERsingle-vision lenses
Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 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; * Has been wearing standard single-vision spectacles regularly for more than six months; * In good general health, capable of receiving the study intervention, and willing to comply with the study protocol; * Written informed consent obtained from both the parent/guardian and the child, with agreement to comply with all study procedures and maintain follow-up availability throughout the study period;
Exclusion criteria
* 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; * Any other condition deemed inappropriate for participation in the clinical trial by the investigator;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | At baseline, 6 months, and 12 months | measured by optical biometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angle of deviation | At baseline, 6 months, and 12 months | measured by alternate cover test with prism |
| Stereopsis | At baseline, 6 months, and 12 months | measured by stereotest booklet |
| Accommodative function | At baseline, 6 months, and 12 months | measured by phoropter |
| Intervention questionnaire | At baseline, 6 months, and 12 months | measured by questionnaire |
| Refractive error | At baseline, 6 months, and 12 months | measured by cycloplegic refraction |
| Best-corrected visual acuity | At baseline, 6 months, and 12 months | measured by visual acuity chart |
| Intraocular pressure | At baseline, 6 months, and 12 months | measured by non-contact tonometer |
| Contrast sensitivity | At baseline, 6 months, and 12 months | measured by quick contrast sensitivity function test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Choroidal thickness (optional) | At baseline, 6 months, and 12 months | measured by OCT, optional |
| Weight | At baseline, 6 months, and 12 months | measured by weighing scale |
| Height | At baseline, 6 months, and 12 months | measured by ruler |
Countries
China
Contacts
Primary ContactJinrong Li, MD PhD
Outcome results
None listed