Dual-focus Soft Contact Lenses for the Treatment of Adult Myopia Progression
University of California, Berkeley
Summary
Myopia (nearsightedness) can continue to worsen during young adulthood, increasing the risk of sight-threatening eye diseases later in life. Although dual-focus soft contacts (DFSC) lenses have been shown to slow myopia progression in children, their effectiveness in adults is not well understood. This study will compare DFSC lenses with standard single-vision soft contact (SVSC) lenses in myopic young adults aged 18 to 30 years. Participants will be randomly assigned to wear one of the two lens types for 24 months. The study will measure changes in axial length and cycloplegic refractive error to determine whether DFSC lenses slow myopia progression in young adults.
Description
This is a prospective, single-center, randomized, double-masked, parallel-group clinical trial designed to evaluate the efficacy of DFSC lenses for slowing myopia progression in young adults. Approximately 152 participants aged 18 to 30 years with documented ongoing myopia progression. will be randomized in a 1:1 ratio to wear either MiSight 1 day DFSC lenses or Proclear 1 day SVSC lenses for 24 months. The co-primary outcomes are changes in axial length and cycloplegic spherical equivalent refractive error over 24 months. Secondary outcomes include changes in choroidal parameters, including t…
Eligibility
- Age range
- 18–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Any gender, aged 18-30 years, inclusive. * Successful previous contact lens wearer * Documented ongoing myopia progression (at least 0.50D over past 2 years) * Refractive error meeting the following by cycloplegic autorefraction: * Myopia -0.50D to -5.00D SER in both eyes * Astigmatism (absolute value) ≤ 1.50 D in both eyes * Anisometropia \< 1.50 D SER. Best-corrected distance visual acuity (BCDVA) in current correction as follows: * 0.1 logMAR or better * Interocular difference ≤ 0.1 log MAR Exclusion Criteria: * Current or previous use of pharmacologic or optical…
Interventions
- DeviceDual Focus Soft Contact Lens
MiSight 1 day is a daily disposable dual-focus soft contact lens with two treatment zones and two distance vision correction zones arranged in concentric rings.
- DeviceSingle Vision Soft Contact Lens
Proclear 1 day is a daily disposable single-vision soft contact lens that provides conventional correction of refractive error without myopia control treatment zones.
Location
- University Of California, Berkeley Myopia Research GroupBerkeley, California