Study Type: Interventional
Study Design: Randomized
Initiator: Iantech Inc., Sean Ianchulev (MD, MPH)
Official Title: A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
Iantech Inc. is a medical device company developing surgical devices, methods and technology for ophthalmology based in the United States of America. They are running a study on their new device technologies to make the removal of cataracts less invasive.
The purpose of the study is to evaluate the clinical outcomes between the conventional phaco procedure and the Low Energy Endocapsular Phaco (LEEP) with micro-interventional lens fragmentation technique. Currently, cataracts are removed via the phacoemulsification method, whereby the eye’s internal lens is emulsified by the vibrations of the phaco probe . Micro-interventional technology developed by Dr. Ianchulev’s team in California uses a novel approach with super-elastic thin-filament fragmentation which reduces pulsatile ultrasonic energy and heat delivered to the eye and can efficiently micro-section and extract the cataract.
Cataracts are natural clouding of the lens that occurs with age as the proteins of the lens begin to degrade . Symptoms are often blurred vision or ultra-sensitivity to light and treatment is surgical removal of the lens . Cataracts are graded on a scale of I-IV: the harder and denser the cataract the higher the grade.
The study was done with a research team at the Clinica de Ojos Orillac-Calvo in Panama City, Panama. There were 150 subjects in the study, Cohort 1 had cataracts Grade II or less and Cohort 2 had cataracts Grade III or higher. Cohort 1 was non-randomized and received the LEEP intervention. Cohort 2 was randomized using Castor so there was an active comparator group which received the LEEP intervention and the control group which received the conventional phaco-assisted lens fragmentation.
The Iantech team was impressed with how user friendly and enabling the system was for their company to run an international study without the burden of paperwork and bureaucracy, while using all the data capture, archiving, verification and monitoring features of Castor. At only a fraction of the cost of other enterprise systems, Castor was deployed and fully operational within several days of finalization of the protocol. We also spoke with Tyler Welling, a researcher on the team, who said he found Castor easy to customize and suited for the team’s research needs.
The study will be wrapping up in the next month once the post-surgery follow-ups have been completed and all the data has been entered.