The Effect of Myopia-Control Contact Lenses in New Zealand Chinese Children

The study will employ a randomized, controlled, investigator-masked paired-eye comparison design to evaluate the effects of two myopia-control contact lenses-MiSight 1 Day and Abiliti 1-Day-in New Zealand Chinese children. The study duration will be 6 months, with assessments conducted at baseline, 2 weeks, 3 months, and 6 months. The clinical research will be conducted at the Auckland Myopia Clinic (New Zealand) and will follow a standard clinical routine for children with early myopia, the only difference being the randomizing of the MiSight and Abiliti contact lenses between the two eyes of the participants.

1. Study Design The study will employ a randomized, controlled, investigator-masked paired-eye comparison design to evaluate the effects of two myopia-control contact lenses-MiSight 1 Day and Abiliti 1-Day-in New Zealand Chinese children. The study duration will be 6 months, with assessments conducted at baseline, 2 weeks, 3 months, and 6 months. The clinical research will be conducted at the Auckland Myopia Clinic (New Zealand) and will follow a standard clinical routine for children with early myopia, the only difference being the randomizing of the MiSight and Abiliti contact lenses between the two eyes of the participants. 2. Participants 2.1 Recruitment and Eligibility Criteria • Participants: 53-66 New Zealand Chinese children aged 7-11 years. * Inclusion criteria: o Spherical refractive error between -1.00D and -4.50D o Astigmatism of ≤1.00D o No history of orthokeratology or atropine use o No ocular diseases or surgical history * Recruitment will be through social media, patient referrals, and school outreach. 2.2 Sample Size A similar study, of soft contact lenses with novel ring focus for controlling myopia progression, based their sample size on treatment efficacy of \>0.08 mm (standard deviation \[SD\]: 0.10) in axial elongation from baseline and \>0.20 D (SD: 0.32) in change of spherical equivalent cycloplegic autorefraction (SECAR) from baseline at 26 weeks. Controlling the 2-sided type I error rate at the 0.05 level, the researchers found that sample size of 40 subjects per group would yield \>80% power for detecting treatment efficacy. To estimate the sample size for the present study, a priori power analysis was performed using the program G∗Power (version 3.1.9.7). For a 95% confidence interval (Z = 1.96) and a study power of 80%, and controlling the 2-sided type I error rate at the 0.05 level, the estimated sample size is 53 pairs of eyes (53 subjects), as each participant contributes both eyes to the study. Providing for a 20% dropout rate, the recruitment target becomes 66 participants. 3. Interventions Each participant will wear: • MiSight 1 Day dual-focus lens in one eye (2.00D defocus) • Abiliti 1-Day lens in the contralateral eye (7.00D defocus) 4. Data Collection Methods 4.1 Baseline and Follow-up Assessments • Cycloplegic refraction (CycloRx) and retinoscopy (Ret) will be conducted. • Axial length will be measured using MYAH optical biometry. • Ocular surface assessments: o Children Dry Eye Questionnaire (CDEQ) responses o Non-invasive Tear break-up time (NIBUT) using MYAH's dry eye function o Ocular Protection Index (OPI) calculation using MYAH * Corneal staining assessment via MYAH corneal staining and slit lamp fluorescein * Lissamine green conjunctiva staining (graded and recorded) 4.2 Timepoints for Data Collection • Baseline (0 months): Cycloplegic refraction, axial length, CDEQ, NIBUT, OPI, corneal staining. * 2 weeks: Axi Покажи пълното описание...

Inclusion Criteria: * Spherical refractive error between -1.00D and -4.50D * Astigmatism of ≤1.00D * No history of orthokeratology or atropine use * No ocular diseases or surgical history Exclusion Criteria: o No ocular diseases or surgical history