Contract research organisation (CRO) Vial has enrolled the first patient in the pivotal COOL-3s clinical study for the assessment of the OcuCool system.
South Korea-based medical device company RecensMedical developed the OcuCool system.
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This clinical study aims to evaluate the long-term safety and efficacy of using the new cooling anaesthesia device for intravitreal injections in the eye.
Patient screening and enrolment in the trial are advancing with the help of Vial CRO’s electronic data capture.
The site team at Texas Retina Associates in Dallas, Texas, led by principal investigator Dr Timothy Fuller, completed screening for the first patient.
Vial Clinical Operations director Wendy Pinson said: “This trial represents a significant milestone in our mission to enhance patient comfort and improve the delivery of intravitreal injection therapy.”
The system features an advanced precision cooling medical device intended for delivering rapid cooling anaesthesia for painless intravitreal injection therapy.
It quickly cools the surface of the eye, attaining a temperature between -5°C and -15°C.
The system offers non-invasive anaesthesia without pharmacologic anaesthetic within ten seconds and has workflow efficiency against existing ophthalmic anaesthesia methods.
This device underwent comprehensive safety studies involving animals and pilot human trials.
RecensMedical CEO Gun-Ho Kim said: “The collaboration with Vial brings us great confidence in the efficient and high-quality execution of this study.
“Together, we aim to expedite the completion of the COOL-3s trial to provide retina specialists with a safe and efficient tool for administering intravitreal injections.”
