Prairie Village

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 eyes 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 fenofibrate compared with a placebo to prevent worsening of diabetic retinopathy DR over six years in adults with mild to moderately severe non-proliferative DR and no center-involved diabetic macular edema at the start. The study also explores how eye doctors might work with primary care providers to safely prescribe and monitor fenofibrate. Additionally, the study will assess how blood sugar fluctuations relate to DR outcomes and include extra research on functional and structural eye changes in participants. Participants receive either fenofibrate or a placebo, with doses of 160 mg or 54 mg daily depending on kidney function, taken with food. The dose may be adjusted during follow-up visits following study guidelines. Treatment and monitoring continue through six years, allowing researchers to compare the effects of fenofibrate against placebo on DR progression. During the study, participants undergo regular eye exams, including grading of fundus photographs and visual acuity tests to monitor retinopathy status. Researchers will track DR worsening as the primary outcome and observe other outcomes such as eye procedures for DR or diabetic macular edema, development of diabetic macular edema affecting vision, and any vision loss. Safety is monitored through kidney function tests and other clinical assessments throughout the six-year follow-up period.

Researchers are evaluating if one day of post-operative prone head positioning is as effective as seven days in patients with retinal detachments involving inferior retinal breaks after pars plana vitrectomy PPV using perfluoropropane C3F8 gas as a tamponade. This single-arm phase II study uses a Simons two-stage design to assess anatomical retina success rates and determine if shorter head positioning is promising for further research. Participants will receive retina re-attachment repair with C3F8 gas tamponade followed by one day of post-operative prone head positioning. The study will enroll 20 patients in two stages 11 patients in the first stage with early stopping rules based on success rates, and if criteria are met, 9 more patients in the second stage. The goal is to achieve retina attachment success in at least 85 of patients. During the study, participants will be monitored for retina attachment using clinical exams with an indirect ophthalmoscope at 3 months and 1 year post-surgery. Researchers will track anatomical success and safety outcomes throughout the follow-up period. The total participation duration varies based on the two-stage design and follow-up assessments. The University of Kansas Medical Center sponsors this trial.

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 studys 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.

This research aims to find the best timing for surgery to remove an epiretinal membrane ERM, a common eye condition affecting vision. It compares immediate surgery versus delaying surgery in patients who have significant changes in the central part of the retina but still relatively good vision. The study also seeks to identify factors that predict how well patients do after surgery or how their condition progresses if surgery is delayed. Additionally, it evaluates tools measuring vision distortion and reading speed to better understand their usefulness for ERM patients. Participants are randomly assigned to one of two groups immediate vitrectomy surgery performed within one month of randomization, or deferred vitrectomy surgery which may be done if vision worsens by specific amounts, symptoms worsen, or complications arise. Surgery involves removing the ERM to improve or stabilize vision. Those in the deferred group are monitored regularly and surgery is only performed if certain criteria are met. Throughout the study, participants will have their vision tested at various times up to 36 months to measure changes in visual acuity. Researchers will also assess vision distortion and reading speed to understand symptoms better. The main outcome measured is the mean change in visual acuity from the start of the study to 36 months. Safety and progression of the condition will be monitored, and participants eye health will be closely followed during the study period.