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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the safety and effectiveness of the smaller incision, new generation implantable miniature telescope SING-IMT in patients aged 65 and older who have moderate to severe central vision loss caused by late-stage age-related macular degeneration AMD. The study focuses on individuals with vision impairment due to geographic atrophy or disciform scars affecting the central retina, conditions related to advanced AMD. Participants who qualify will undergo implantation of the SING-IMT device during routine cataract surgery. The device consists of two micro lenses within a glass tube mounted on a flexible silicone carrier and is inserted through an approximately 6.5 mm incision using a proprietary delivery system. After implantation, patients will attend five follow-up visits over about 12 months and may receive up to 12 rehabilitation or training sessions with a low vision specialist to help adapt to the device. Throughout the study, participants will have their best-corrected distance and near visual acuity checked, including tests with and without refraction and with an external telescope simulator to assess potential benefit. Researchers will monitor safety and effectiveness outcomes approximately 12 months post-surgery, including measurements of visual acuity, anterior chamber depth, device positioning, adverse events, and posterior capsule opacification. The total study involvement lasts about one year following surgery, with ongoing assessments and rehabilitation support.
Actively Recruiting
This research aims to evaluate the effectiveness of the PrEP for Health behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis PrEP among people who inject drugs PWID at risk of HIV infection. The trial involves 200 PWID recruited from two syringe service program SSP sites in Lawrence and BostonCambridge, Massachusetts. Researchers will compare this intervention with standard care to see if it increases PrEP uptake and adherence over time. Participants are randomly assigned to one of two groups the PrEP for Health intervention group or the standard of care group. The intervention group receives theory-based HIV and PrEP education, motivational interviewing, problem-solving and planning support, and ongoing patient navigation for three months. The standard care group receives PrEP information via a brief video and referrals to PrEP clinicians. Assessments occur at baseline and at 1, 3, 6, and 12 months after randomization. Participants will complete four follow-up visits during the 12-month study period, including rapid HIV testing at 12 months. Those who start PrEP will provide hair samples at 3, 6, and 12 months to measure adherence through drug levels. Researchers will evaluate PrEP uptake at 3 months and adherence at 3, 6, and 12 months. The study also examines how intervention effects vary by participant characteristics and monitors participant engagement through counseling and navigation support.