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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the DRISTi automated screening tool to diagnose Diabetic Retinopathy including mtmDR, PDR, and DME in patients with diabetes. The study invites adults diagnosed with diabetes mellitus to participate by having eye images taken. These images will be analyzed by the DRISTi AI software and an ophthalmic reading center to compare results and complete statistical analysis for validation. Participants will have ophthalmic images taken and graded by the fully automated DRISTi AI device. The study is observational and involves no study drug or treatment. The primary outcome measure is the accuracy of the AI grading, assessed from arrival to completion of diagnostic tests within a maximum of 8 hours. There is no randomization or placebo group. During the study, participants will consent and comply with study procedures including imaging and data collection. Researchers will evaluate the AIs diagnostic accuracy compared to the ophthalmic reading centers evaluation. Participants may be monitored for any safety concerns related to imaging procedures. The study allows for the inclusion of adults aged 21 years or older diagnosed with diabetes mellitus, and participation duration varies by individual.

Age: 21Years +All Genders
2 locations
C

Actively Recruiting

This research aims to compare two surgical methods for upper eyelid surgery called blepharoplasty, which removes excess skin that can affect peripheral vision and appearance. The study uses a split-face design where one eyelid undergoes traditional surgery using a blade, cautery, and sutures, while the other eyelid is treated with Ziplyft, a clamp device that compresses the skin to prevent bleeding and uses tissue adhesive instead of sutures. The goal is to evaluate bruising, wound healing, surgery time, and satisfaction from both patients and surgeons. Participants will have one eyelid treated with standard blepharoplasty involving blade removal, blood vessel cautery, and suturing, and the other eyelid treated with Ziplyft which compresses skin to stop bleeding, allowing incision closure with tissue adhesive. Both sides will have equal amounts of skin removed. The surgeon will record the time taken for each procedure. Follow-up photos will be taken at 3, 7 days, and 1 month after surgery to assess bruising and incision healing. During the study, participants will be evaluated with independent professional review of post-operative photos to measure bruising and incision appearance. Both patient and surgeon surveys will capture satisfaction levels up to two months after surgery. The study tracks wound closure success and compares surgical case times. Follow-up visits and evaluations will ensure comprehensive monitoring of outcomes and participant experience.

Age: 35Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Age: 18Years +All Genders
2368 locations