Clinical Study to Develop and Evaluate a Multifunctional Ophthalmic Measurement Device for Eye Health

What this Trial Is About

Researchers are evaluating a multifunctional ophthalmic measuring device designed for eye examinations. This clinical investigation aims to refine the devices design by adjusting light source intensity, camera settings, and acquisition time to cover a wide range of patients. The study will also assess the safety and clinical performance of the device for measuring parameters related to conditions such as accommodation disorder, keratoconus, dry eye, and refractive errors. The investigation involves a single visit for each of the 378 participants, who will undergo measurements using the investigational device. The device will capture images and parameters of the anterior and posterior chambers of the eye, including axial biometry and physiological features of the anterior chamber. These measurements are collected during the visit to evaluate the devices ability to successfully acquire the intended data. Participants will be assessed during one visit at the study center, where various eye measurements will be taken using the device. Researchers will monitor the frequency of successful measurements to determine the devices clinical performance. Participants must be able to sit upright in front of the device for the evaluation. Safety and effectiveness will be recorded, and the study is expected to end in August 2025.

Clinical Investigation for a Multifunction Ophthalmic Measurement Device