AffaMed Technologies, a joint venture between AffaMed Therapeutics and SIFI S.p.A., has announced the completion of the first patient implantation in the regulatory clinical trial for its MINI WELL progressive Extended Depth-of-Focus (EDOF) intraocular lens (IOL). The procedure was successfully conducted at the EYE & ENT Hospital of Fudan University in Shanghai, China, under the leadership of Professor Yi Lu, Director of the Ophthalmic Research Institute, and his study team. This marks a significant milestone in the development of innovative ophthalmic solutions.
MINI WELL IOL: Innovation in Ophthalmology
Developed by SIFI S.p.A., a leading international ophthalmology company headquartered in Italy, MINI WELL EDOF IOL is an innovative implant designed for the Greater China market. It offers a superior alternative to traditional refraction, diffraction, and segment-type mono/bi/tri-focal IOLs, as well as diffraction-type EDOF IOLs. MINI WELL is the first progressive EDOF aspheric IOL for presbyopia correction, designed to be implanted via a mini-incision and positioned in the posterior chamber of the eye through a capsular bag.
Clinical Application and Benefits
MINI WELL IOL is intended for primary implantation for visual correction of aphakia in adult patients with or without presbyopia after the removal of a cataractous lens. It is also used for aphakia correction after refractive lensectomy in presbyopic adults who desire increased spectacle independence for distance and near vision. As the world’s first Wavefront progressive EDOF IOL, MINI WELL offers excellent visual acuity at far, intermediate, and near distances. It improves reading speed at a 40cm distance, provides smooth vision transition from near to far, maintains contrast sensitivity within a normal range, and minimizes halos and glare, resulting in high patient satisfaction.
Future Prospects
The successful first patient implantation of MINI WELL IOL is a testament to AffaMed Technologies’ commitment to advancing ophthalmic care. This innovative IOL has the potential to transform the treatment landscape for presbyopia and cataract patients, offering a new standard of visual correction. As the clinical trial progresses, AffaMed Technologies aims to gather robust data to support the broader adoption of MINI WELL IOL, enhancing the quality of life for patients in need.-Fineline Info & Tech