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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are comparing the effectiveness and safety of the ELIOS device versus a competitor device in patients with open-angle glaucoma who are undergoing cataract surgery. The study focuses on lowering intraocular pressure IOP at 12 months after surgery. This prospective, multicenter, randomized clinical trial aims to assess which device better reduces IOP in this patient group. Participants will receive cataract surgery followed by treatment with either the ELIOS device or the competitor device, assigned randomly. Both treatments are procedures performed by the surgeon immediately after cataract surgery. The trial compares these two active treatment groups in a parallel design. Participants will be monitored for intraocular pressure at 12 months and again at 24 months after washout. The study also tracks the number of hypotensive medications used and measures treated IOP at 12 months. Safety and effectiveness will be evaluated throughout the follow-up period, which extends until December 2028.
Actively Recruiting
Researchers are studying patients with stage II primary invasive cutaneous melanoma to compare the effects of two different surgical excision margins 1cm versus 2cm. The goal is to determine if narrower margins are as safe as wider margins in preventing melanoma recurrence and if they can improve patients quality of life. This trial also looks at the impact of these excision sizes on health services and society. Participants will be randomly assigned to receive either a 1cm or 2cm wide local excision margin around the primary melanoma lesion. Both groups will undergo sentinel lymph node biopsy and may have reconstruction surgery if needed. The surgery must be done within 120 days of diagnosis and within 28 days of randomization. During the study, participants will be followed for up to 60 months to measure disease-free survival as the primary outcome. Additional assessments include local recurrence, distant disease-free survival, melanoma-specific and overall survival, quality of life questionnaires, neuropathic pain evaluations, adverse event monitoring, and health economic analysis. Follow-up questionnaires and safety checks will occur at multiple time points up to 24 months after surgery, with longer-term monitoring continuing up to 120 months.
Actively Recruiting
Glaucoma is a common eye disease leading to permanent vision loss and blindness, especially among people over 50 years old. Open-angle glaucoma OAG develops slowly as fluid drainage in the eye becomes blocked, increasing eye pressure and damaging the optic nerve. This trial investigates whether adding oral nicotinamide a form of Vitamin B3 to standard pressure-lowering treatments can reduce vision loss in recently diagnosed OAG patients and evaluates the long-term safety and effectiveness of nicotinamide. Participants will be randomly assigned to one of two groups one receiving nicotinamide and the other a matching placebo, both alongside their usual care for lowering eye pressure. The treatment lasts up to 27 months, starting with 1.5 grams per day of nicotinamide or placebo for six weeks, then increasing to 3.0 grams per day for the rest of the period. This study is double-masked, so neither participants nor investigators know which treatment is given. During the trial, participants will undergo regular eye exams including visual field tests to measure vision changes up to 27 months. Researchers will also assess quality of life, liver and kidney function, blood glucose, and record any adverse events. These assessments will help determine the impact of nicotinamide on slowing vision loss and its safety profile over time.