Incidence of Postsurgical Intraocular Inflammation 6 Months After Implantation with a Multifocal Intraocular Lens.

Purpose: This study assessed the incidence of postsurgical intraocular inflammation after cataract extraction by phacoemulsification and implantation with AcrySof IQ ReSTOR intraocular lenses (IOLs) produced using an updated manufacturing process. Incidence rates were compared with historical rates of postsurgical intraocular inflammation. Methods: This was a prospective, multicenter, post-approval study at 34 sites. Patients aged ≥22 years received a study lens in at least 1 eye. Postsurgical intraocular inflammation (aqueous cell grade ≥3+ within 14 days after surgery, aqueous cell ≥2+ at 14 to ≤60 days after surgery, or aqueous cell ≥1+ at >60 days) was assessed within a 180-day period after implantation. Rates of toxic anterior segment syndrome (TASS), acute postoperative endophthalmitis, chronic postoperative endophthalmitis, and uncategorized cases of postsurgical intraocular inflammation were assessed. Ocular adverse events (AEs) and ocular adverse device effects (ADEs) were evaluated. Historical rates of postsurgical intraocular inflammation were determined from the 2011-2013 Medicare Limited Data Set files (a 5% sample of the Medicare data set representative of patients aged ≥65 years). Results: Final safety analysis set included 3357 eyes (1792 patients; mean age, 68.6 ± 7.9 years). Postsurgical intraocular inflammation (any type) rate was 5.1 per 1000 attempted IOL implants (95% CI, 2.95, 8.10). TASS, acute postoperative endophthalmitis, and uncategorized inflammation rates were 0.6 (95% CI, 0.07, 2.15), 0.3 (95% CI, 0.01, 1.66), and 4.2 (95% CI, 2.28, 6.99) per 1000 attempted IOL implants, respectively. There were no events of chronic postoperative endophthalmitis. Ocular AEs and ADEs were reported in 17% and 1.5% of eyes, respectively. Most common ADEs were halo (0.63%) and glare (0.51%). The historical postsurgical inflammation rate from 221,519 cataract procedures was 10.3/1000 cataract surgeries, and the endophthalmitis rate was 1.2/1000 surgeries. Conclusion: The updated IOL manufacturing process resulted in postoperative intraocular inflammation rates that were substantially lower than the historic rate.

Academy IRIS® Registry Analysis of Incidence of Laser Capsulotomy Due to Posterior Capsule Opacification After Intraocular Lens Implantation.

Purpose: Academy IRIS® (Intelligent Research in Sight) Registry was used to determine the incidence of postoperative neodymium-doped yttrium aluminum garnet laser capsulotomy (Nd:YAG) and time to posterior capsular opacification (PCO) diagnosis based on intraocular lens (IOL) type and brand. Methods: This retrospective analysis included eyes implanted with 1 of 2 IOL brands, with ≥365 days of follow-up available in the IRIS Registry, and ≥2 visits within 180 days of surgery. Analyses included Nd:YAG incidence due to PCO within 1 year after surgery by IOL type and brand, mean time to PCO diagnosis, and mean time to Nd:YAG. Results: Of 89,947 eyes after cataract surgery, 24,834 (28%) had PCO diagnosis within 365 days, and 9262 (10%) underwent Nd:YAG; 4.1% of 57,523 eyes with monofocal and 21.2% of 32,424 eyes with diffractive multifocal (MF) or diffractive extended depth of focus (EDOF) IOLs had Nd:YAG. Nd:YAG was 3.2 times more likely in eyes with diffractive MF or diffractive EDOF IOLs versus monofocal. For monofocal IOLs, 3.2% of eyes with AcrySof® and 8.1% of eyes with Tecnis® had Nd:YAG (P<0.0001). For diffractive MF or diffractive EDOF IOLs, 13.0% of eyes with AcrySof and 21.7% of eyes with Tecnis had Nd:YAG (P<0.0001). Nd:YAG risk was 2.4 times higher in eyes with Tecnis versus AcrySof IOLs. Overall, mean time to PCO diagnosis and Nd:YAG was 150.7 and 180.7 days. Mean time to PCO for monofocal versus diffractive MF or diffractive EDOF IOLs was 165.3 versus 139.7 days (P<0.0001). Mean time to Nd:YAG for monofocal versus diffractive MF or diffractive EDOF IOLs was 196.4 versus 175.3 days (P<0.05). Conclusion: Real-world data for AcrySof and Tecnis IOLs revealed lower Nd:YAG rates and longer time to PCO diagnosis and Nd:YAG after monofocal versus diffractive multifocal or diffractive EDOF implantation. Nd:YAG rates were significantly lower with AcrySof versus Tecnis IOLs.

The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study.

PURPOSE: To compare the AcrySof Toric intraocular lens (IOL) and an AcrySof spherical control IOL and to investigate rotational stability of the AcrySof Toric IOL (Alcon Laboratories, Inc., Fort Worth, TX) in subjects with cataracts and preexisting corneal astigmatism. DESIGN: Randomized, subject-masked, parallel-group, multicenter, 1-year study. PARTICIPANTS: We included 517 subjects (Toric IOL, n = 256; control IOL, n = 261). METHODS: Unilateral implantation of an AcrySof Toric or AcrySof spherical control IOL (spherical powers, 12.00-25.00 diopters [D]; cylinder powers 1.50, 2.25, or 3.00 D for corneal astigmatism correction of 0.75 to < 1.50, ≥ 1.50 to <2.00, and ≥ 2.00 D with no upper limit, respectively). No limbal relaxing incisions were permitted. MAIN OUTCOME MEASURES: Visual acuity outcomes, IOL position, patient-reported spectacle use, and safety. RESULTS: One year postoperatively, best spectacle-corrected distance visual acuity of ≥ 20/20 was 77.7% (Toric IOL) versus 69.2% (control IOL). Uncorrected distance visual acuity of 20/20 or better was 40.7% (Toric IOL) versus 19.4% (control IOL; P<0.05). Mean absolute residual refractive cylinder was 0.59 D (Toric IOL) versus 1.22 D (control IOL; P<0.0001). Mean rotation was < 4° (range, 0°-20°) for the Toric IOL. Six-month spectacle freedom was 61.0% (Toric IOL) and 36.4% (control IOL; P < 0.0001). Complications in both groups were few and were as would be expected with cataract surgery. CONCLUSIONS: Favorable efficacy, rotational stability, distance vision spectacle freedom, and safety results support the use of the AcrySof Toric IOL for patients with cataracts and corneal astigmatism. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Status of toric intraocular lenses.

PURPOSE OF REVIEW: To provide an update on the status of toric intraocular lenses. These lenses can be used as an alternative or adjunct to corneal astigmatic incisions for correcting preexisting astigmatism in patients with cataracts. They are a particularly attractive option in those cases where limbal-relaxing incisions are not powerful or predictable enough. Other toric lenses may correct astigmatism in addition to spherical refractive errors in phakic patients. RECENT FINDINGS: Toric lenses have continued to gain popularity with the US Food and Drugs Administration (FDA) approval of the Acrysof Toric intraocular lenses. This lens is designed to be implanted in patients undergoing cataract removal and who have significant preexisting corneal astigmatism. In the FDA clinical trial, study patients received one of the three cylindrical powers, and control patients received a standard monofocal intraocular lenses. The study found that the Acrysof Toric intraocular lenses provided excellent visual outcomes and exhibited excellent rotational stability. With the Acrysof Toric intraocular lenses, the average lens rotation was less than 4 degrees from the lens' initial placement at 6 months after surgery. SUMMARY: Toric intraocular lenses provide excellent vision for astigmatic cataract patients, and new designs are significantly improving visual acuity by minimizing the risk of rotation.