Contact Lenses to Slow Myopia Progression in Adults

Official title

Dual-focus Soft Contact Lenses for the Treatment of Adult Myopia Progression

Overview

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

• Device Dual 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.
• Device Single 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.

Primary outcome measures

• Cycloplegic Spherical Equivalent Refraction [Time frame: Baseline, 12 months, and 24 months]
• Axial Length [Time frame: Baseline, 12 months, and 24 months]

Secondary outcome measures (5)

• Acute Change in Choroidal Thickness [Time frame: Baseline (pre-lens adaptation) and immediately following 30 minutes of contact lens wear (post-lens adaptation).]
• Quality of Vision [Time frame: Baseline, 2 weeks, 12 months, and 24 months]
• Accommodative Response [Time frame: Baseline, 2 weeks, 6 months, 12 months, and 24 months]
• Ocular Safety [Time frame: Baseline through 12 months and Baseline through 24 months]
• Longitudinal Change in Choroidal Thickness [Time frame: Baseline, 6 months, 12 months and 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University Of California, Berkeley Myopia Research Group — Berkeley

Publications

• McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26. PMID 20505205
• Brennan NA, Cheng X, Bullimore MA. Adult Myopia Progression. Invest Ophthalmol Vis Sci. 2024 Nov 4;65(13):49. doi: 10.1167/iovs.65.13.49. PMID 39576624
• Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2. PMID 37126362

Identifiers

NCT: NCT07747311 · 2022-09-15618

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗