The enVista Aspire<sup>™</sup> Toric Advantage

In a recent conversation, Dr. Kamran M. Riaz, clinical professor, Thelma Gaylord Endowed Chair in Ophthalmology, and Vice-Chair of Clinical Research at the Dean McGee Eye Institute at the University of Oklahoma in Oklahoma City, Oklahoma, discussed his experience with the enVista Aspire Toric intraocular lens (IOL). Dr. Riaz detailed the IOL’s intermediate optimized optic, and advantages in patients with astigmatism, along with data from a real-world study that was presented at the Clinical Trials at the Summit meeting in 2024.

Intermediate Optimized Optic

Dr. Riaz noted that while monofocal IOLs provide excellent vision at distance, patients may need spectacles to see at intermediate distances. He added that the new enVista Aspire Toric takes the already excellent enVista platform one step further with a design that adds additional power in the center of the IOL optic to allow for a broader depth of focus.^a As a hydrophobic acrylic monofocal intermediate optimized IOL, the enVista Toric is designed to provide the same distance visual acuity as standard monofocal IOLs.^1,2

Outstanding performance and optical engineering are built into the design of every enVista lens. The intermediate optimized central zone utilizes higher-order aspheric coefficients on the posterior surface and showed an increase in depth of focus compared to the enVista IOL.^a Also, the lens has a controlled curvature change technology designed to harmonize the geometric power profile outward between the central base power and power at the periphery. Finally, it uses a unique optic to create a gradual transitional distribution of light energy from the center to the periphery, an optic feature designed to minimize dysphotopsias.³

Ability to Remove Cataracts and Correct Astigmatism at the Same Time

As little as 0.50 diopters (D) of astigmatism has the potential to affect functional and low-contrast visual acuity that can have an impact on the visual comfort of computer users.⁴ The Low-Cyl correction technology of the enVista Aspire Toric allows surgeons to expand the range of astigmatism they can treat during cataract surgery with an IOL, compared to other monofocal toric options, and correct as low as 1.0 D of astigmatism at the corneal plane.⁵ In fact, the Aspire Toric is the only Low-Cyl monofocal toric IOL below 1.5 D that is commercially available in the US.⁵

Real-World Study With Aspire Toric

Dr. Riaz conducted a retrospective chart review to evaluate the real-world clinical outcomes of 94 patients who were implanted with an enVista Aspire IOL during cataract surgery.³ Five of these patients received the enVista Aspire Toric lens.³

Real-World Study With enVista Aspire: Design³

In eyes implanted with the enVista Aspire lens, good uncorrected and corrected distance vision outcomes were observed, similar to a monofocal IOL.³

Real-World Study With enVista Aspire: Distance Vision³

CDVA, corrected distance visual acuity; MRSE, manifest refraction spherical equivalent; UDVA, uncorrected distance visual acuity.

Additionally, eyes implanted with the enVista Aspire lens also showed good outcomes in uncorrected intermediate vision.³

Real-World Study With enVista Aspire: Intermediate Vision³

UIVA, uncorrected intermediate visual acuity.

Implantation of the enVista Aspire lens required no postoperative IOL exchange. The incidence of postoperative complications among 94 total eyes (cystoid macular edema, rebound iritis, and posterior capsule opacification requiring YAG^b surgery in the first 90 days) was low (4.3%).³ In the five patients who received the toric lens, good outcomes were observed in uncorrected and corrected distance and intermediate vision, with 100% and 80% of eyes achieving postoperative CDVA and UIVA of 20/30 or better, respectively.³

Conclusion

All in all, the enVista Toric platform allows the surgeon to elevate the everyday, transcending the boundaries of standard monofocal IOLs by utilizing higher-order aspheric coefficients on the posterior surface to allow for a broader depth of focus.³ Dr. Riaz concluded, “In the real-world study, the enVista Aspire monofocal plus IOL had good refractive outcomes and an excellent safety profile.”

^aBased on optical bench testing - MTF study in ISO2 (+0.28µm) model cornea.
^bYttrium Aluminum Garnet

References

Saenz B, Lopez C, Sepulveda R. Keeping up with the newest IOLs. Rev Optometry. December 15, 2023. Accessed July 11, 2024.
Lau GM, Hosten L, Kolesnitchenko V. Evaluation of enhanced monofocal plus IOLs with extended depth of focus. ARVO Annual Meeting Abstract. IOVS. 2023;64(8).
Riaz KM. Real-world clinical outcomes of enVista Aspire IOL. Presentation at Clinical Trials at the Summit (CTS), June 8-9, 2024, Park City, Utah.
Miller AD, Kris MJ, Griffiths AC. Effect of small focal errors on vision. Optom Vis Sci. 1997;74(7):521-526. doi: 10.1097/00006324-199707000-00020.
enVista Aspire Toric Directions for Use, Bausch + Lomb.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

enVista Aspire Toric Intraocular Lens

INDICATIONS: The enVista Aspire™ toric hydrophobic acrylic IOL (non-preloaded model ETA) 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.

DEVICE DESCRIPTION: The Aspire IOL uses 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 extend the depth of focus. However, clinically meaningful extension of the depth of focus has not been demonstrated in clinical trials.

WARNINGS: 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; (8) 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.

PRECAUTIONS: 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). The safety and effectiveness of the IOL have not been substantiated in patients with pre-existing ocular conditions and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting an IOL in a patient with one or more of these conditions. Physicians considering IOL implantation in such patients should explore the use of alternative methods of aphakic correction and consider IOL implantation only if alternatives are deemed unsatisfactory in meeting the needs of the patient. Patients with preoperative problems, such as corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from IOL implantation when such conditions exist.

ADVERSE EVENTS: As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon transient or persistent glaucoma, and secondary surgical intervention. Secondary surgical interventions include but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: This is not all you need to know. Please refer to the Directions For Use labeling for a complete listing of indications, full risk and safety information, clinical study information, etc.

Intermediate Optimized Optic

Ability to Remove Cataracts and Correct Astigmatism at the Same Time

Real-World Study With Aspire Toric

Real-World Study With enVista Aspire: Design3

Real-World Study With enVista Aspire: Distance Vision3

Real-World Study With enVista Aspire: Intermediate Vision3

Conclusion

Sign up to receive updates on Bausch + Lomb Surgical

Real-World Study With enVista Aspire: Design³

Real-World Study With enVista Aspire: Distance Vision³

Real-World Study With enVista Aspire: Intermediate Vision³