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High Levels of Safety and Efficacy for New Aspheric Monofocal Lens
Dermot McGrath reports from the 39th Congress of the ESCRS in Amsterdam
The Clareon® aspheric monofocal lens delivered excellent visual outcomes and stable refractive results with very low rates of posterior capsule opacification (PCO) for up to two years after implantation, according to Rudy MMA Nuijts MD, PhD, who presented the two-year interim results of the IOL study.
“The two-year visual outcomes were excellent, with stable refractive results. There were no unanticipated adverse events, and very low rates of PCO and Nd:YAG capsulotomies were observed,” he said.
Conducted at 16 different study centres in Europe and three in Australia, the ongoing prospective, multinational, single-arm trial is assessing the long-term safety and effectiveness of the Clareon (Alcon Vision LLC) lens implanted in patients who required bilateral cataract extraction.
Discussing the properties of the lens, Professor Nuijts described it as a novel monofocal aspheric hydrophobic lens composed of flexible acrylic material with a high refractive index. Based on the AcrySof® platform, the foldable, singlepiece IOL is designed for implantation in the capsular bag through a 2.2 mm incision using the dedicated AutonoMe™ preloaded injector system.
“The Clareon has been developed with an improved manufacturing process yielding a smoother surface, patented edge profile, and improved water distribution, leading to reduced glistening formation,” he said.
Inclusion criteria for the study were adults more than 22 years of age with bilaterally visually significant cataract and a preoperative best-corrected distance visual acuity (BCVA) worse than 0.2 logMAR in the better-seeing eye. The IOL power was calculated to achieve a postoperative spherical equivalent within 0.50 D of emmetropia using the available IOL range of +15.00 D to +25.00 D.
Of 245 patients initially enrolled, 215 were implanted, 209 of which were bilateral cases. At two years postoperatively, a total of 190 first eyes (88.4%) and 189 second eyes were available for analysis, Prof Nuijts reported.
At two years, the postoperative monocular mean corrected distance visual acuity (CDVA) was 0.03 logMAR in first and second eyes, and more than 96% of eyes had CDVA of 20/25 or better.
The mean manifest refractive spherical equivalent was also within target by one week postoperatively and maintained at 0.06 D in first and second eyes at two years. There were no unanticipated adverse events.
Clinically significant posterior capsule opacification (PCO) was reported for 3 first (1.4%) and 5 second (2.4%) eyes. Clinically significant PCO requiring Nd:YAG laser capsulotomy was reported for 3 first (1.4%) and 5 second (2.4%) eyes. Grade 0 glistenings were reported in 386 out of 387 eyes.
The efficacy and safety of the Clareon lens was confirmed by a 12-month multicentre clinical trial at 16 sites carried out in the United States and presented by David Lubeck MD.
Of 342 patients who completed the study, more than 99% achieved monocular CDVA of 0.3 logMAR or better, and 87% achieved monocular CDVA of 0.04 logMAR or better. The most common non-serious adverse event was posterior capsule opacification in 5.4%, with an Nd:YAG laser rate of 4.6% at 12 months.
Rudy MMA Nuijts MD, PhD, is Professor of Ophthalmology, Vice Chairman, and Director of the Cornea Clinic and the Center for Refractive Surgery at the University Eye Clinic Maastricht, Maastricht University Medical Center (MUMC), the Netherlands. rudy.nuijts@mumc.nl
