Alcon yesterday announced findings from the American Academy of Ophthalmology (AAO) IRIS® Registry (Intelligent Research in Sight) that support the clinical value of the AcrySof® platform. The IRIS Registry was used to assess characteristics and complications of intraocular lens (IOL) implantation after cataract surgery.
AAO launched the IRIS Registry, the specialty’s first comprehensive national database, in 2014. As the largest clinical specialty database in the world, the IRIS Registry currently includes clinical information from more than 15,000 participating eye care physicians and 252 million patient visits, representing more than 60 million unique patients. AAO developed this registry with the goal of striving for continual improvement in the delivery of eye care. In addition, the real-world data is useful for clinical care, analytics and regulatory compliance.
The study findings presented at AAO followed a cohort-based protocol and were completed in collaboration with Verana Health, the Academy’s data curation and analytics partner. Results from an analysis of the 6,482 eyes implanted with a TECNIS* or an AcrySof monofocal toric IOL, presented in poster and paper presentations by Dr. Brent Kramer, demonstrated that the incidence of post-operative repositioning was significantly lower at a rate of 0.6% in the AcrySof group compared to 3.1% in the TECNIS group (P<0.0001). Additionally, the rate of undergoing IOL repositioning surgery was over five times higher among patients who received TECNIS lenses compared with those who received AcrySof lenses.
“Toric IOL misalignment can lead to poor visual outcomes and patient dissatisfaction,” said John Berdahl, MD, of Vance Thompson Vision in Sioux Falls, SD, who was a co-author on these presentations. “This analysis corroborates other studies which demonstrate the excellent rotational stability of AcrySof IOLs. This large dataset can help surgeons make informed choices regarding toric IOL selection.”
In a separate analysis of the IRIS Registry, the incidence of YAG laser capsulotomy due to posterior capsular opacification (PCO) and time to PCO after lens implantation was compared between types and brands of IOLs in over 78,000 eyes. In a poster authored by Dr. Jeffrey Horn, YAG rates with monofocal lenses were lower than multi-focal/extended depth of focus lenses (4.5% vs 22.4%, P<0.0001). For monofocal YAG rates, AcrySof lenses were significantly lower than TECNIS lenses (3.7% vs 7.8%, P < 0.0001). In another poster authored by Dr. Bret Fisher, the mean time to PCO diagnosis was significantly longer in the AcrySof monofocal group (171.1 ±99.3 days) versus the TECNIS monofocal group (155.2 ±96.0 days), P<0.0001.
“The IRIS Registry is the most robust resource for real-world data and clinical outcomes in the U.S.,” said Dr. Stephen Lane, Chief Medical Officer, Alcon. “By evaluating parameters such as repositioning rates and YAG incidence due to posterior capsular opacification between different types of IOLs, we can provide surgeons with valuable information to enhance their clinical knowledge and patient outcomes. Being able to analyze such immense amounts of information has the ability to revolutionize clinical practice and demonstrates the value of the data in this registry along with Alcon’s commitment to providing the highest integrity data in the industry.”
Full news release: https://www.alcon.com/about-us#media-releases