Sartell

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups: one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone; the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

Researchers are studying children aged 4 to 7 years with amblyopia to compare two treatments: watching dichoptic movies or shows using the Luminopia headset versus patching the fellow eye. The goal is to see if the Luminopia headset treatment used one hour per day, six days per week, is not worse than patching for two hours per day, seven days per week, in improving vision in the amblyopic eye over 26 weeks. This phase 3 randomized trial evaluates changes in distance visual acuity as the primary outcome. Participants will be randomly assigned to one of two groups. One group uses the Luminopia headset to watch dichoptic content for one hour daily (which can be split into shorter sessions) six days a week, wearing optical correction if needed. The other group uses an eye patch on the fellow eye for two hours daily (also split into shorter sessions) seven days a week, with optical correction as needed. After 26 weeks, those initially in the patching group who still have significant vision difference may be offered the Luminopia treatment and followed for an additional 26 weeks. Throughout the study, participants will undergo clinical assessments at 13 and 26 weeks, with follow-up visits at 39 and 52 weeks for those switching to Luminopia. Researchers will measure changes in distance visual acuity in the amblyopic eye, tracking treatment effects over time. Parents will maintain communication with the study team, and participants will continue using required spectacles or contact lenses. The total study duration varies up to 52 weeks depending on treatment response and group assignment.

Researchers are evaluating dichoptic treatments for children aged 8 to 12 years with amblyopia, a condition affecting vision. This phase 3 randomized trial compares two types of virtual reality-based dichoptic therapy, Luminopia and Vivid Vision, against continued use of optical correction alone. The study aims to understand how these treatments impact vision improvement, specifically measuring changes in the amblyopic eye's visual acuity. Participants are randomly assigned to one of three groups: Luminopia, involving watching dichoptic movies or shows using a headset for 1 hour daily six days a week; Vivid Vision, playing dichoptic video games with a headset for about 25 minutes daily six days a week; or continuing optical correction with glasses or contact lenses alone. Those initially assigned to optical correction alone who show limited improvement after 18 weeks may be re-randomized to receive one of the dichoptic therapies, with follow-up visits extending to 36 weeks. During the study, participants attend clinical assessments at 9 and 18 weeks after starting treatment, with additional visits at 27 and 36 weeks for some. Researchers measure visual acuity changes in the amblyopic eye using the logMAR scale and assess quality of life related to vision through a pediatric eye questionnaire. The study includes monitoring adherence to treatment, willingness to wear the headset and optical correction, and safety considerations throughout the 18 to 36-week participation period.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.