Oceanside

Researchers are evaluating the effectiveness, safety, and pharmacokinetics of the Port Delivery System (PDS) with ranibizumab compared to standard intravitreal ranibizumab injections in adults with diabetic macular edema (DME). This Phase III, multicenter, randomized study aims to compare PDS treatment every 24 weeks with injections every 4 weeks. A substudy will assess the safety of re-implanting the updated PDS and performing refill-exchange procedures in participants previously enrolled in the main study. Participants will receive either the PDS implant pre-filled with ranibizumab or intravitreal ranibizumab injections according to their assigned group. Treatments will be administered on a set schedule specific to each arm. The substudy involves re-implantation of the updated PDS and monitoring post-procedure. The PDS refill exchange is also part of the treatment plan for some participants. Throughout the study, participants will undergo assessments including vision tests using the ETDRS chart to measure changes in best-corrected visual acuity (BCVA). Safety will be monitored by tracking ocular and systemic adverse events, device-related effects, and any serious complications up to 72 weeks after treatment or re-implantation. The study evaluates both short-term and long-term safety and efficacy outcomes over the full duration of participation.

Researchers are evaluating the safety and effectiveness of the VIS Opti-K System in improving near vision temporarily by treating the non-dominant eye of adults aged 40 and older with presbyopia, which includes those who are low myopic, emmetropic, or have low hyperopia. This Phase III trial focuses on measuring uncorrected near visual acuity at 40 cm in the treated eye and patient satisfaction with the treatment. The study aims to provide temporary monovision correction to help with near vision challenges related to aging. Participants will receive treatment using the VIS Optimal Laser Keratoplasty (Opti-K) device, which applies laser therapy to the cornea of the non-dominant eye. The treatment is designed to improve near vision while maintaining distance vision. The study includes a primary treatment period and follow-up assessments to monitor visual acuity and patient satisfaction. The treatment is delivered as a single procedure, and participants are monitored for changes in vision over time. During the study, participants will undergo various vision tests, including measurements of uncorrected near visual acuity and best corrected distance visual acuity. They will complete patient satisfaction questionnaires to report subjective improvements. Researchers will also check corneal health and stability of refraction before treatment. Safety and effectiveness will be evaluated over at least 3 months by tracking changes in vision and any adverse effects. Participants must comply with follow-up visits and study procedures to ensure accurate monitoring of outcomes.

Researchers are evaluating the accuracy of a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM) in pregnant individuals aged 18 to 50 years. This pilot study enrolls participants receiving prenatal care at Mount Sinai Hospital to better understand how well CGM works compared to standard glucose testing methods. The study focuses on a group with singleton pregnancies between 24 and 32 weeks gestation. Participants will use a continuous glucose monitor device, which is a sensor placed on the upper arm that continuously measures glucose levels in the fluid under the skin and sends data to a mobile app. The study involves wearing the CGM for 10 days to collect glucose data, alongside standard glucose tolerance tests during pregnancy and monitoring blood glucose shortly after childbirth. During the study, participants will be monitored through glucose data collected by the CGM over 10 days, glucose tolerance tests at 1 and 3 hours, and a postpartum blood glucose measurement 4 hours after delivery. The study includes regular prenatal appointments at Mount Sinai Hospital, where informed consent is obtained and ongoing monitoring takes place to assess glucose levels and the CGM device's validity in this setting.