Myopia, Myopia Progression
Conditions
Keywords
myopia, adult myopia, myopia progression, MiSight
Brief 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.
Detailed 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 thickness, accommodation, and ocular safety. Outcome assessors will remain masked to treatment allocation throughout the study.
Interventions
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.
Proclear 1 day is a daily disposable single-vision soft contact lens that provides conventional correction of refractive error without myopia control treatment zones.
Sponsors
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
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 myopia control treatment within the past 2 years. * Any ocular disease or abnormality affecting the cornea, lens, retina, iris, ciliary body, choroid, or sclera. * History of manifest strabismus, amblyopia, or nystagmus. * Previous eyelid, strabismus, intraocular, or refractive surgery. I- ntraocular pressure \>26 mmHg. * of premature birth (≥6 weeks before the due date). * Neurological disorders, genetic syndromes, or other conditions that would interfere with completion of study procedures. * Known allergy or hypersensitivity to fluorescein, proparacaine, or tropicamide. * Conditions associated with degenerative myopia or abnormal ocular anatomy (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, keratoconus, lenticonus, or spherophakia). * Regular use of ocular medications, artificial tears, or wetting agents. * Current use of systemic medications that may affect contact lens wear, tear film, pupil size, accommodation, electrophysiology, or refractive state. * Diagnosis of or treatment for attention-deficit/hyperactivity disorder (ADHD) or a learning disability. * Systemic disease that may affect visual function (e.g., diabetes mellitus). * Ocular inflammation within 30 days before screening. * Slit-lamp findings that contraindicate contact lens wear (e.g., corneal scars, corneal neovascularization, giant papillary conjunctivitis). * Blepharospasm or other eyelid abnormalities that interfere with contact lens wear. * Any severe ocular or systemic condition that, in the investigator's judgment, would interfere with study participation or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic Spherical Equivalent Refraction | Baseline, 12 months, and 24 months | Change in cycloplegic spherical equivalent refraction (diopters) from baseline, measured by cycloplegic autorefraction after instillation of 1% tropicamide. Spherical equivalent will be calculated as sphere + one-half cylinder. The mean change from baseline will be compared between the DFSC and SVSC lens groups. |
| Axial Length | Baseline, 12 months, and 24 months | Change in axial length (millimeters) from baseline. The mean change from baseline will be compared between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Change in Choroidal Thickness | Baseline (pre-lens adaptation) and immediately following 30 minutes of contact lens wear (post-lens adaptation). | Change in subfoveal choroidal thickness (µm) measured using swept-source optical coherence tomography (SS-OCT) immediately before and after a 30-minute adaptation period while wearing the assigned contact lens. |
| Quality of Vision | Baseline, 2 weeks, 12 months, and 24 months | Change from baseline in quality of vision assessed using the Quality of Vision (QoV) Questionnaire, a previously validated patient-reported outcome measure comprising three Rasch-scaled subscales (Frequency, Severity, and Bothersome), each ranging from 0 to 100, with higher scores indicating worse quality of vision. Subscale scores will be compared between treatment groups at the prespecified study visits. |
| Accommodative Response | Baseline, 2 weeks, 6 months, 12 months, and 24 months | Change from baseline in dynamic accommodative response (diopters) measured objectively over a range of accommodative demands using the Shack-Hartmann aberrometer. Responses will be compared between treatment groups. |
| Ocular Safety | Baseline through 12 months and Baseline through 24 months | Cumulative incidence of ocular and contact lens-related adverse events occurring from baseline through 12 months and from baseline through 24 months will be compared between treatment groups. |
| Longitudinal Change in Choroidal Thickness | Baseline, 6 months, 12 months and 24 months | Change in subfoveal choroidal thickness (µm) measured using swept-source optical coherence tomography (SS-OCT) over the study period to evaluate the longitudinal effect of the assigned contact lens. |
Countries
United States
Contacts
CONTACTRanjila Shyangbo
CONTACTSarah Singh, OD, PhD, FAAO
PRINCIPAL_INVESTIGATORSarah Singh
University of California, Berkeley
STUDY_DIRECTORRanjila Shyangbo
University of California, Berkeley
Outcome results
None listed