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Found 4 Actively Recruiting clinical trials

D

Actively Recruiting

The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children. * To assess if the DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.75D in cycloplegic spherical equivalent autorefraction refractive error compared to single-vision (SV) spectacles over the study period. * To assess if DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.3mm in axial elongation compared to SV over the study period. The clinical trial will compare DG1 spectacle lens to single vision spectacle lens. Participants will wear spectacle lenses and return for visits at regularly scheduled intervals through a 36-month follow up visit. All subjects who complete the 36-month visit will continue in the study for an additional 12 months for the rebound evaluation.

Age: 7Years - 10YearsAll GendersPhase Not Applicable
10 locations
E

Actively Recruiting

Healthy Volunteer

Researchers are evaluating a new type of spectacle lens to control myopia progression in children aged 6 to 8 years. This randomized, controlled, multisite trial aims to confirm findings from previous studies and predict treatment effects over three years by assessing efficacy at 12 months. The study focuses on juvenile myopia and its progression. Participants are randomly assigned to one of two groups: one group uses a novel single vision, impact-resistant spectacle lens designed to reduce myopia progression, while the other group wears standard single vision, impact-resistant spectacle lenses. Both groups wear their assigned spectacles daily, except during sleep, swimming, or activities where wearing glasses is unsafe. The study runs for 24 months without allowing contact lens use. Children will undergo various eye measurements including visual acuity, axial length, and refractive error assessments at baseline and during follow-up visits. Researchers will measure spherical equivalent refraction after 12 months to evaluate treatment efficacy. Parents or guardians must consent and commit to the full study duration, ensuring adherence to spectacle wear and study procedures. The trial monitors safety and effectiveness through regular eye exams and data collection over two years.

Age: 6Years - 8YearsAll GendersPhase Not Applicable
14 locations
M

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effectiveness and visual symptoms of the MiSight 1 Day contact lens in children aged 8 to 12 years with myopia. The study aims to confirm the lens's ability to slow the progression of myopia in clinical practice in the US and assess how stable the reduction in myopia remains after one year without treatment. This is a multicenter, randomized, double-masked clinical trial lasting four years, divided into two parts. In Part 1, participants are randomly assigned to wear either MiSight 1 Day lenses or Proclear 1 Day lenses for three years to compare their effects on myopia progression. In Part 2, all participants wear Proclear 1 Day lenses for one additional year to study the stability of the myopia control after stopping the MiSight lenses. Both participants and investigators remain masked to the treatment assignments from Part 1. Participants will attend scheduled visits for eye examinations including measurements of spherical equivalent refractive error and axial length. Researchers will monitor visual acuity, eye health, and myopia progression over the four-year period. The main outcomes measured are the changes in refractive error and axial length after three years and the rate of change during the one-year post-treatment period. Participants are expected to wear the lenses about 10 hours daily, six days per week, and maintain follow-up visits throughout the study.

Age: 8Years - 12YearsAll GendersPhase Not Applicable
30 locations
N

Actively Recruiting

This research aims to evaluate the safety and effectiveness of several types of comfilcon A contact lenses, including Sphere, Toric, Multifocal, Toric Multifocal, and Energys lenses. The study focuses on their performance after 2 hours of wear in a general population that includes people with conditions such as astigmatism, presbyopia, and ametropia. Participants will wear one of the comfilcon A lenses for 2 hours during the study. The lenses being assessed are designed to address different vision needs, and each type will be tested for how well it performs and how safe it is during this short wear period. During the study, researchers will measure visual performance, including visual acuity, and monitor any contact lens-related adverse events at the end of the 2-hour wear period. Participants who meet the eligibility criteria will be involved in the study for the time needed to complete these assessments.

Age: 8Years - 75YearsAll Genders
4 locations
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