Contact Lenses to Slow Myopia Progression in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of California, Berkeley
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any gender, aged 18-30 years, inclusive.
Successful previous contact lens wearer
Documented ongoing myopia progression (at least 0.50D over past 2 years)
Myopia -0.50D to -5.00D SER in both eyes
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dual Focus Soft Contact Lens
DeviceMiSight 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.
Single Vision Soft Contact Lens
DeviceProclear 1 day is a daily disposable single-vision soft contact lens that provides conventional correction of refractive error without myopia control treatment zones.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cycloplegic Spherical Equivalent Refraction
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.
Time frame
Baseline, 12 months, and 24 months2
Axial Length
Change in axial length (millimeters) from baseline. The mean change from baseline will be compared between two groups
Time frame
Baseline, 12 months, and 24 monthsSecondary outcomes
1
Acute Change in Choroidal Thickness
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.
Time frame
Baseline (pre-lens adaptation) and immediately following 30 minutes of contact lens wear (post-lens adaptation).2
Quality of Vision
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.
Time frame
Baseline, 2 weeks, 12 months, and 24 months3
Accommodative Response
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.
Time frame
Baseline, 2 weeks, 6 months, 12 months, and 24 months4
Ocular Safety
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.
Time frame
Baseline through 12 months and Baseline through 24 monthsOther outcomes
1
Choroidal vascularity index (CVI)
Change from baseline in choroidal vascularity index (CVI), measured using swept-source optical coherence tomography (SS-OCT), to evaluate longitudinal changes during contact lens treatment.
Time frame
Baseline, 6 months, 12 months, and 24 months.Sponsors and contacts
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Source ClinicalTrials.gov
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