Announcement • Sep 03

Bausch + Lomb Publishes New Research On EnVista Aspire And EnVista Aspire Toric Intraocular Lenses

Bausch + Lomb Corporation announced the publication of new research on real world experience with enVista Aspire and enVista Aspire toric intraocular lenses (IOLs). The study, published in the journal Ophthalmology and Therapy, found that these enhanced monofocal lenses delivered both good distance and functional intermediate vision, thus meeting the needs of many cataract patients. In this multicenter, real-world study, six U.S.-based cataract surgeons provided a sample of cataract surgery cases and completed a retrospective experience survey, which captured outcomes including corrected and uncorrected distance visual acuity (CDVA and UDVA), uncorrected intermediate visual acuity (UIVA), refractive outcomes and safety. The sample included a total of 84 patients and 141 eyes (88 for enVista Aspire and 53 for enVista Aspire toric). In the enVista Aspire patient group, 97.2% attained a monocular CDVA of 20/25 or better, 71.3% attained a monocular UDVA of 20/25 or better and 76.6% attained a monocular UIVA of 20/32 or better at the last reported follow up appointment. In the enVista Aspire toric group, 94.9% reached a monocular CDVA of 20/25 or better, 84.9% reached a monocular UDVA of 20/25 or better and 93% reached a monocular UIVA of 20/32 or better at the last reported follow up appointment. 100% of subjects in both groups realized a binocular UIVA of 20/32 or better. No serious adverse events were recorded. Unlike standard monofocal IOLs, the enVista Aspire monofocal optic broadens vision beyond distance alone, into the intermediate range. Like the enVista monofocal IOL, enVista Aspire offers a glistening-free optic material and controlled, efficient unfolding through Bausch + Lomb’s proprietary StableFlex Technology, which aids optic recovery. For patients with astigmatism, enVista Aspire Toric IOLs provide a proven option for treatment of their astigmatism during cataract surgery. From a low cylinder design, +1.25D in the US and +0.90D (IOL plane) in markets outside of the US, enVista toric platform covers a wide range of treatment for patients with corneal astigmatism. The unique AccuSet haptic design enables exceptional rotational stability, an important attribute for toric lenses. The enVista Aspire hydrophobic acrylic IOL (non-preloaded model: EA /preloaded into shuttle models: EPA, EC20A, EC24A) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia following removal of a cataractous lens. The enVista Aspire toric hydrophobic acrylic IOL (non-preloaded model: ETA /preloaded into shuttle models: ETPA, ETC20A, ETC24A) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia and corneal astigmatism following the removal of a cataractous lens for improved uncorrected distance vision. The enVista Aspire and enVista Aspire toric IOLs use an optical modification of the posterior aspheric surface to create a small continuous increase in IOL power within the central 1.5 mm diameter to slightly broaden the depth of focus. enVista Aspire and enVista Aspire toric IOLs: Physicians considering IOL implantation under any of the following circumstances should weigh the potential risk/benefit ratio: (1) Recurrent severe anterior or posterior segment inflammation or uveitis; (2) Patients in whom the IOL may affect the ability to observe, diagnose, or treat posterior segment diseases; (3) Surgical difficulties at the time of cataract extraction, which might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss); (4) A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; (5) Circumstances that would result in damage to the endothelium during implantation; (6) Suspected microbial infection; (7) Patients in whom neither the posterior capsule nor zonules are intact enough to provide support. enVista Aspire toric IOL only: Rotation of the IOL away from the intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, IOL positioning should occur prior to capsule fibrosis and IOL encapsulation. Neither the safety and effectiveness, nor the effects of the Aspire IOL optical design on depth of focus, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have been evaluated clinically. MTF testing of the Aspire IOL optical design (used in model ETA) may aid the surgeon in understanding the theoretical image quality expected with the Aspire IOL compared to the enVista monofocal IOL MX60E. However, these do not fully assess all aspects of clinical difficulties under all conditions. Surgeons must weigh the potential benefits of the modified optical design of the Aspire IOL (model ETA) against the potential for risks associated with a degradation in vision quality and the lack of clinical data to characterize the impact of the Aspire IOL optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain pre-existing ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc).

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