Unique polymer material
Research conducted by Gerd U. Auffarth, MD, PhD, and colleagues confirms that Clareon’s novel hydrophobic acrylic biomaterial resists glistening formation. They used a laboratory model that accelerates formation of these fluid-filled microvacuoles and image analysis software to quantify their number, size, and volume.
“This model exposes the IOL to tough testing conditions and the results showed that the new biomaterial lived up to expectations in terms of retaining optical purity,” said Dr. Auffarth, professor and chairman, Department of Ophthalmology, and director, International Vision Correction Research Centre, University of Heidelberg, Heidelberg, Germany.
Analysis of the central area of the optic where glistening is likely to develop first showed a mean glistening count of just 4.09 microvacuoles/mm2. That value translates into a rating of 0 on the Miyata Scale for clinical glistening grading and classifies the material as “glistening free.”
Another in vitro study investigated the interaction between the novel biomaterial and a cohesive ophthalmic viscosurgical device (OVD; ProVisc, Alcon) after implantation in porcine eyes and an autopsy eye model. The results showed that the OVD was easy to remove. In addition, the IOL demonstrated excellent positional stability in the capsular bag during OVD removal.
“It is important that surgeons who are comfortable and happy with the intraocular behavior of the AcrySof IOLs not feel there are unwanted differences using this new IOL,” Dr. Auffarth said. “We found that the time taken to perform complete removal of the OVD in eyes implanted with the Clareon IOL averaged about 26 seconds and was not significantly different compared with the AcrySof IOL.”
Another study evaluating capsular bag performance showed that compared with an AcrySof IOL, there was a larger arc of contact between the IOL haptic and capsular bag equator with the Clareon IOL. With the Clareon IOL, there was also less capsular bag striae and ovalization.
“The material of the Clareon IOL is softer and it seems to fit better in the capsular bag compared with the AcrySof IOL,” Dr. Auffarth said.
Yet another laboratory investigation found that silicone oil adhesion to the new biomaterial was also low.