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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. Follow-up visits will be scheduled at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Lens replacement will be arranged if a refractive change greater than 0.50 diopters occurs or if the lenses become severely damaged |
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| Control group | Placebo Comparator | Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12-months. Follow-up visits will be scheduled at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Lens replacement will be arranged if a refractive change greater than 0.50 diopters is detected or if the lenses become severely damaged. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| light-blocking lenses | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | measured by optical biometer | At baseline, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive error | measured by cycloplegic refraction | At baseline, 6 months, and 12 months |
| Best-corrected visual acuity | measured by visual acuity chart |
| Measure | Description | Time Frame |
|---|---|---|
| Height | measured by ruler | At baseline, 6 months, and 12 months |
| Weight | measured by weighing scale | At baseline, 6 months, and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinrong Li, MD PhD | Contact | 86-020-87330351 | lijingr3@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D015858 | Anisometropia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| single-vision lenses | Other | Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months. |
|
| At baseline, 6 months, and 12 months |
| Intraocular pressure | measured by non-contact tonometer | At baseline, 6 months, and 12 months |
| Angle of deviation | measured by alternate cover test with prism | At baseline, 6 months, and 12 months |
| Contrast sensitivity | measured by quick contrast sensitivity function test | At baseline, 6 months, and 12 months |
| Stereopsis | measured by stereotest booklet | At baseline, 6 months, and 12 months |
| Accommodative function | measured by phoropter | At baseline, 6 months, and 12 months |
| Intervention questionnaire | measured by questionnaire | At baseline, 6 months, and 12 months |
| Choroidal thickness (optional) | measured by OCT, optional | At baseline, 6 months, and 12 months |