Development of a New Optical Biometer to Measure Eyes With Cataract for Cataract Surgery Planning

What this Trial Is About

Researchers are evaluating a new device called the Helioscope, developed by Cassini Technologies B.V., which combines LED-based corneal topography with swept-source optical coherence tomography SS-OCT to quickly and accurately measure the shape of the cornea and other eye structures. This next-generation optical biometer is designed to provide measurements even in eyes with dense cataracts, which can affect optical properties and measurement accuracy. The study aims to collect data from eyes with cataracts to help improve the devices software algorithms. Participants will have their eye measurements taken in a single visit using three devices the investigational Helioscope optical biometer, and two FDA-cleared comparator devicesthe Cassini Ambient corneal topographer and the Argos optical biometer. These measurements will be compared to evaluate the accuracy and agreement of the new device. There is no treatment or intervention assignment as part of this study it focuses solely on diagnostic comparison. During the study visit, participants will undergo ocular biometry to measure parameters such as axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism using all three devices. Researchers will monitor the measurements over a period of up to 12 months to assess the Helioscopes performance in cataractous eyes. Safety is ensured by selecting participants able to provide informed consent and properly fixate during measurements.

Development of Optical Biometer