Clinical Scorecard: Randomized Clinical Trial of Highly Aspherical Lenslet Spectacle Lenses for Myopia Control

At a Glance

Key Highlights

• The double-masked trial randomized participants 1:1 to highly aspherical lenslet (HAL) or single-vision spectacle lenses.
• Randomization was stratified by site, age group, and baseline myopia severity.
• Primary outcomes were changes from baseline in cycloplegic spherical equivalent refraction and axial length.
• Participants were instructed to wear study spectacles for at least 10 hours daily on 6 days each week.
• Safety assessments included adverse events, best-corrected visual acuity, and symptoms, problems, and complaints.

Guideline-Based Recommendations

Diagnosis

• Trial eligibility required manifest spherical equivalent refraction from −0.75 to −4.50 D and astigmatism of 1.50 D or less; lenses were dispensed only when cycloplegic SER was ≤−0.50 D.

Management

• The investigational HAL lens combined a single-vision refractive correction zone with a myopia-control zone containing 11 contiguous highly aspherical lenslet rings.
• The control intervention was a standard single-vision spectacle lens.
• Participants were instructed to wear study spectacles for a minimum of 10 hours per day on 6 days per week.

Monitoring & Follow-up

• Cycloplegic autorefraction assessed spherical equivalent refraction annually; axial length was measured every 6 months.
• At each visit, safety assessments included ocular and nonocular adverse events, visual acuity, and symptoms, problems, and complaints.
• Spectacle compliance was monitored by wear frequency and duration.

Risks

• The article states that greater myopia severity is associated with higher risk of pathologic myopia.
• Safety assessments included ocular and nonocular adverse events; the supplied excerpt does not report trial safety results.

Patient & Prescribing Data

Healthy children aged 6 to 12 years with manifest spherical equivalent refraction from −0.75 to −4.50 D and astigmatism of 1.50 D or less; lenses were dispensed only when cycloplegic SER was ≤−0.50 D. Exclusions included previous myopia-control interventions, strabismus, amblyopia, and conditions or medications affecting refractive status.

Clinical Best Practices

• Trial eligibility used cycloplegic refraction to confirm myopia.
• The trial's primary outcomes were changes in cycloplegic spherical equivalent refraction and axial length.
• Trial safety assessments included visual acuity and ocular and nonocular adverse events.
• The trial monitored spectacle wear frequency and duration.

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