Prairie Village

Researchers are evaluating treatments for amblyopia in children aged 4 to 7 years. The study compares watching dichoptic movies or shows using the Luminopia virtual reality headset for 1 hour per day, 6 days per week, to traditional eye patching for 2 hours per day, 7 days per week. This Phase 3 trial aims to determine if the Luminopia treatment is not worse than patching in improving vision in the weaker eye over 26 weeks. Participants will be randomly assigned to either the Luminopia headset group or the patching group. Clinical assessments occur at 13 and 26 weeks after starting treatment. At 26 weeks, those initially assigned to patching who show less improvement may choose to try Luminopia therapy and continue follow-up visits at 39 and 52 weeks. Other participants will end the study at 26 weeks. During the study, children will have their vision tested at scheduled visits to measure changes in distance visual acuity in the amblyopic eye. Researchers will monitor treatment adherence and safety. The total participation can last up to 52 weeks for some children, with primary outcomes assessed at 26 weeks to evaluate vision improvement.

Researchers are evaluating treatments for amblyopia in children aged 8 to 12 years. The trial compares two types of dichoptic therapy delivered through virtual reality headsets—Luminopia presenting movies and shows, and Vivid Vision offering video games—against continued optical correction alone. The study aims to understand how these treatments affect visual acuity in the amblyopic eye over an 18-week period. Participants will be randomly assigned to one of three groups: Luminopia dichoptic treatment, Vivid Vision dichoptic treatment, or optical correction alone, all with optical correction as needed. Treatments are provided for 19 weeks, with dichoptic therapies involving daily sessions of either viewing or gameplay through a headset. If participants initially assigned to optical correction alone show insufficient improvement at 18 weeks, they may be re-randomized to receive one of the dichoptic therapies and followed up at 27 and 36 weeks. The study concludes for others at 18 weeks. During the study, participants undergo clinical assessments at 9 and 18 weeks after randomization to measure changes in visual acuity of the amblyopic eye using logMAR distance measures. Researchers monitor adherence to treatment, willingness to wear headsets and glasses, and optical correction stability. Safety and effectiveness are assessed by comparing visual outcomes across groups, with additional follow-up visits for some participants extending to 36 weeks total participation.

Researchers are evaluating the effect of fenofibrate compared with placebo in preventing worsening of diabetic retinopathy (DR) over six years in people with mild to moderately severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) at the start. The study also aims to test a model where ophthalmologists collaborate with primary care providers like internists or endocrinologists to safely prescribe and monitor the drug. Additionally, the study will assess how blood sugar variability relates to DR outcomes and will include additional studies to understand functional and structural eye changes in participants. Participants will receive either fenofibrate or placebo daily with food, with the dose (either 160mg or 54mg) chosen based on kidney function measured at screening. The dose may be adjusted during follow-up according to the study protocol. The trial is randomized and includes a comparison between the fenofibrate and placebo groups. During the study, participants will be monitored for worsening of diabetic retinopathy over six years. Eye health will be assessed through specialized grading of fundus photographs and visual acuity tests. Kidney function and blood sugar variability will also be tracked. The main outcome measured is the progression of diabetic retinopathy. Researchers will observe safety and effectiveness while participants remain in the study for the full six-year period.

Researchers are evaluating if one day of post-operative prone head positioning is as effective as seven days in patients who have retinal detachments with inferior retinal breaks following pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. This single-arm phase II study uses a Simon's two-stage design to test whether the treatment success rate is 85% or higher compared to a futility rate of 60%. The goal is to determine if shorter head positioning duration could maintain retina attachment after surgery. Participants will receive retina re-attachment repair with C3F8 gas tamponade and be assigned to one day of post-operative prone head positioning. The study plans to enroll up to 20 patients in two stages. In the first stage, 11 patients will be enrolled and assessed for treatment success. If sufficient success is achieved, an additional 9 patients will be recruited. The trial monitors retina attachment outcomes to evaluate if the shorter positioning is promising for further research. During the study, participants will be monitored for retina attachment success using clinical exams with an indirect ophthalmoscope at 3 months after surgery, which is the primary outcome. Secondary outcomes include retina attachment at 1 year post-operatively. Safety and compliance with post-operative treatment will also be observed. Participants must be followed throughout the study period to assess anatomical success and any complications related to the retinal detachment repair.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

This research aims to improve understanding of the best timing for surgery in patients with symptomatic epiretinal membrane (ERM), a common condition affecting the macula in the eye. The study compares early vitrectomy surgery to remove the ERM versus delaying surgery until vision worsens, to see which approach leads to better visual outcomes. It also seeks to identify factors that predict outcomes after surgery or progression if surgery is deferred, and evaluates the usefulness of measures for visual distortion and reading speed in these patients. Participants will be randomly assigned to one of two groups: one receiving immediate vitrectomy surgery within one month of randomization to remove the ERM, and the other having deferred vitrectomy surgery only if certain vision loss criteria are met, symptoms worsen, or complications arise. Surgery is the main intervention, and the study will closely monitor participants over time to compare these approaches. Throughout the study, researchers will assess changes in visual acuity, distortion symptoms, and reading speed. Visual acuity letter scores will be measured from baseline up to 36 months to evaluate outcomes. Participants undergo regular eye exams and imaging to monitor the macula and ERM status, and their vision and symptoms are tracked to determine the best management approach. The study aims to provide detailed information on how timing of surgery affects vision and quality of life over three years.