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  • A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23) Rochester, Minn. In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.
  • A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles plus Patching for Amblyopia in Children 3 to < 13 Years Old (ATS22) Rochester, Minn.

    The purpose of this study is to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone, followed by patching (if needed), for previously untreated amblyopia in children 3 to < 13 years of age.

     

     

  • Clinical Study of the ARTISAN Aphakia Lens for the Correction of Aphakia in Children Rochester, Minn.

    To determine the effectiveness of the ARTISAN Aphakia lens in the treatment of aphakia and to precisely define the associated risks and, if possible, identify particular groups of patients who may be at high risk of developing complications resulting from the surgical procedure of implanting an ARTISAN Aphakia lens.

  • Evaluating Patient Reported Outcome Measures in Children with Eye Conditions (PedEyeQ) Rochester, Minn.

    The objectives of this study are:

    • To evaluate patient-reported quality of life and functional vision across the spectrum of pediatric eye conditions;
    • To assess change in patient-reported quality of life and functional vision over time;
    • To compare the impact of different treatments on quality of life and functional vision;
    • To assess change in patient-reported quality of life and functional vision in response to treatment;
    • To determine associations between quality of life / functional vision scores and specific clinical and demographic characteristics.
  • Home Visual Acuity Testing (X06) Rochester, Minn.

    Management of most pediatric eye conditions requires periodic monitoring of visual acuity (VA).
    In many cases, particularly the treatment of amblyopia, measurement of VA is the key clinical
    outcome of the clinical examination done in the office. However, transporting children and
    teenagers to and from the care provider’s office to obtain follow-up measurements of VA can be
    difficult due to the need to take time off work and school. In addition, transportation can be a
    barrier because of access or cost or both. Additionally, the recent emergence of the COVID-19
    pandemic and subsequent global “shelter in place” and “lockdown” precautions have further
    highlighted the need for a validated method of measuring VA at home, to enable the monitoring
    of eye conditions in the context of telemedicine.
    The present study is designed to evaluate whether VA measured at home by a parent or guardian
    using the age appropriate ATS-HOTV or e-ETDRS testing protocol on an iPhone-based
    application (hereafter referred to as “phone-based” method) will result in measurements similar to
    those collected during an office visit at an eye clinic using the same testing protocol on a study
    certified EVA or M&S visual acuity tester (hereafter referred to as “office-based” method).

  • IXT7:Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children (IXT7) Rochester, Minn.

    The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of Intermittent Exotropia (IXT) after 3 months of treatment (ontreatment outcome).

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