Efficacy and Safety of Integrated Positive Lenslet Array Peripheral Hyperopic Defocus Lenses on Emmetropization in Moderate-to-High Hyperopic Children: A Randomized Controlled Trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Control group:Single Vision Lens;Intervention group:Integrated Positive Lenslet Array Peripheral Hyperopic Defocus Spectacles; CONDITION: Moderate to high hyperopia in children PRIMARY OUTCOME: choroidal thickness;Axial Length; SECONDARY OUTCOME: horizontal strabismus magnitude;weight;Intraocular pressure;stereoacuity;Accommodative Facility;cycloplegic spherical equivalent;Convergence Function;retinal dioptric power;Height;vision;contrast sensitivity;Amplitude of Accommodation; INCLUSION CRITERIA: 1.Age: Children and adolescents aged 6–16 years, without gender restriction; 2.Subjects with spherical equivalent refraction (SE) >= +3.00 D in both eyes at initial visit and a minimum of 3 Months of continuous spectacle correction wear. 3.Astigmatism <= 2.00 D, interocular anisometropia < 1.50 D; 4.Best corrected visual acuity (BCVA) >= 0.8; 5.Able to comply with the trial protocol and cooperate to complete reliable study measurements;
Epistemonikos ID: b31a4cf0ddb5ae1df3dacbbaa1da21a57fed6f1f
First added on: Oct 08, 2026