Xi’an Eyedeal’s xPIB Intraocular Lens Clinical Trial Completes Its Enrollment

Xi’an Eyedeal Medical Technology announced that it completed the enrollment of its xPIB intraocular lens clinical trial on July 21st, 2022. Eyedeal xPIB intraocular lens is the latest world-class innovative IOL for cataract. It represents the world leading advance in ophthalmic implantable device .

The trial, a multicenter, randomized, open-label, parallel-controlled study, is designed to evaluate the safety and efficacy of xPIB IOL implanted in patients after cataract removal. Hundred and eighty-eight (188) patients were enrolled from multiple clinical centers across the country, including Hangzhou, Xi’an, Jinan, Shantou, and Changsha. The study report will be submitted to NMPA, upon completion of 12 months follow-up of all enrolled subjects.

Several special reports presented at the world academic conferences by Gerd Auffarth, professor of Heidelberg University and chairman of the German Cataract Society, as well as Professor Len Pinchuk, a renowned Fellow of the American Academy of Engineering, indicated that chronic inflammation , glistening, and opacity of the IOL are reduced with the uniform molecular structure and excellent biological properties of xPIB biomaterial. The incidence of secondary cataract is also expected to be lower . With high refractive index and high Abbe number (low dispersion), the chromatic aberration of Eyedeal xPIB intraocular lens was effectively reduce. Moreover, the superior elasticity property of the material makes it possible for larger optical diameter IOL  (diameter greater than 6.5mm) to go through less than 2mm incision. Therefore, the surgical-induced astigmatism, halo, glare and other unwanted effects are expected to be reduced subsequently with larger optical diameter.

Once approved, Xi’an Eyedeal xPIB intraocular lens could be a more advanced and ideal player in the future IOL market. Therefore it will provide a better choice and meet unmet needs for cataract patients worldwide. The completion of the trial enrollment is no-doubt an important milestone for the product.