Not yet recruiting NCT07142928
Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children
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: light-blocking lenses, single-vision lenses.
- Who it may be relevant to
- Registry conditions: Anisometropia, Hyperopia. Basic parameters: 6 years — 12 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Controlled Trial on the Effect of Light-Blocking Lenses on Emmetropization in Hyperopic Anisometropic Children
Overview
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
- Other light-blocking lenses
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 - Other single-vision lenses
Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.
Primary outcome measures
- Axial length [Time frame: At baseline, 6 months, and 12 months]
Secondary outcome measures (8)
- Refractive error [Time frame: At baseline, 6 months, and 12 months]
- Best-corrected visual acuity [Time frame: At baseline, 6 months, and 12 months]
- Intraocular pressure [Time frame: At baseline, 6 months, and 12 months]
- Angle of deviation [Time frame: At baseline, 6 months, and 12 months]
- Contrast sensitivity [Time frame: At baseline, 6 months, and 12 months]
- Stereopsis [Time frame: At baseline, 6 months, and 12 months]
- Accommodative function [Time frame: At baseline, 6 months, and 12 months]
- Intervention questionnaire [Time frame: At baseline, 6 months, and 12 months]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Ophthalmic Center — Guangzhou
Identifiers
NCT: NCT07142928 · 2025KYPJ092