Contact Lenses to Slow Myopia Progression in Adults

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.

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.