ianTECH Inc. (now ZEISS) is a medical device company based in the United States that develops surgical devices, methods and technology for ophthalmology. They conducted studies on their new device, miLOOP, which was designed to make the removal of cataracts less invasive.
The purpose of the study was 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 [1]. The miLOOP micro-interventional technology developed by ianTECH 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.
-
Industry
Medical Device Companies
-
Challenge
Efficiently running a randomized controlled trial
-
Solution
A user-friendly and powerful EDC platform
-
Result
Successfully established device safety and performance
Challenge: Efficiently running a randomized controlled trial
ianTECH Founder Dr. Sean Ianchulev conducted the study with a research team at the Clinica de Ojos Orillac-Calvo in Panama City, Panama. There were 101 subjects in the trial – 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 needed to be randomized so there was an active comparator group which received the LEEP intervention and the control group which received the conventional phaco-assisted lens fragmentation. ianTECH was looking for an easy to use platform to randomize Cohort 2 and seamlessly capture data for this international study.
How to randomize records in Castor EDCSolution: A user-friendly and powerful data platform
ianTECH selected Castor EDC for its user-friendly interface and tools. They stated that the platform enabled their team to efficiently run an international study without the burden of paperwork and bureaucracy. ianTECH used several of Castor’s features to complete the trial, including electronic data capture, archiving, randomization, verification and monitoring. Tyler Welling, a researcher on the team, said he found Castor easy to customize and well suited for the team’s research needs.
Explore Castor's medical device data platform“I actually didn’t need to watch the tutorial videos. I just jumped right in and explored the system.”
Sean Ianchulev, MD, MPH, Founder, ianTECH
Result: Successfully established the safety and performance of miLOOP
At only a fraction of the cost of other enterprise systems, Castor EDC was deployed and fully operational within several days of finalization of the protocol. ianTECH was then able to capture data on their 101 subjects over the course of one weekend!
Congratulations to Dr. Sean Ianchulev and his team for successfully establishing the safety and performance of miLOOP and publishing their results in the British Journal of Ophthalmology. miLOOP was then purchased by ZEISS in October of 2018!