Real-world Data Shows Vivity Good for Distance, Intermediate, and Functional Near Vision

Cataracts are the most common cause of vision loss globally and the primary cause of preventable blindness in the world. Cataract surgery involves removing the clouded natural crystalline lens followed by a replacement with an intraocular lens (IOL). The latest innovation in IOL technology is the presbyopia correcting IOL (PC-IOL). Presbyopia involves the gradual loss of the eye’s ability to focus on close objects such as smartphones, computers, books, and menus. Almost everyone will experience presbyopia to some degree as they age, with symptoms often first appearing as an individual enters their 40s, and continuing to worsen into their 60s.

The AcrySof IQ Vivity IOL, a wavefront shaping PC-IOL with Alcon’s proprietary X-WAVE technology, expands the depth of focus to allow for improved range of vision with monofocal-like distance vision performance

The AcrySof IQ Vivity IOL, a wavefront shaping PC-IOL with Alcon’s proprietary X-WAVE technology, expands the depth of focus to allow for improved range of vision with monofocal-like distance vision performance.^1-2 It delivers a continuous range of vision from distance (far) to intermediate (at arm’s length, e.g., reading the newspaper, working on a laptop), while providing functional near (up close, e.g., reading books, mobile phone), with a low rate of visual disturbances.^2-4 

Research data, from a study supported by Alcon, found that AcrySof IQ Vivity IOL gives good distance, intermediate and functional near visual outcomes, as well as high patient satisfaction from an on-going multi-country, ambispective registry study.⁵

Professor Michael Lawless et al presented overall real-world (interim) data on a subgroup of 674 cataract patients implanted bilaterally with AcrySof IQ Vivity at least three months after surgery,⁵ finding:

• The binocular mean Å}SD uncorrected distance visual acuity (UCDVA) was 0.016Å}0.104 logMAR, uncorrected intermediate visual acuity (UCIVA) was 0.088Å}0.119 logMAR, and uncorrected near visual acuity (UCNVA) was 0.253Å}0.157 logMAR.
• No halos, glare or starbursts were reported by 92.3%, 93.1%, and 95.5% of the patients respectively.
• Over 80% of patients reported never or rarely needing glasses to see at arm’s length and far away, in both bright and dim light.
• Patient satisfaction with sight was high, with 92.3% reporting they were both satisfied with their sight.

A multicentre, ambispective registry study is being conducted to investigate real-world visual outcomes in subjects bilaterally implanted with AcrySof IQ Vivity PC-IOLs (models DFT015 and DFTX15- Toric) through routine clinical practice, involving a total of 757 subjects at the second interim analysis.

Dr Armand Borovik presented a sub-analysis⁶ of the second interim dataset, where 256 subjects were implanted with the toric version of the AcrySof IQ Vivity IOL. After approximately three months follow-up per local clinical practice standards, subjects underwent visual acuity assessments at distance, intermediate (66cm) and near (40cm) distances. Residual refractive error, subject satisfaction, and spectacle independence, recorded via validated questionnaires, as well as visual disturbances, were also reported.⁶ This data revealed that:

• The subjects achieved binocular mean logMAR (SD) UCDVA 0.022 (0.107); UCIVA 0.086 (0.116) and UCNVA 0.252 (0.159).
• 83% of all eyes had ≤ 0.50D of manifest refractive cylinder after surgery.
• 88.0% of subjects reported rarely or never needing glasses at arm’s length (bright light) and 90.9% were satisfied with their sight.
• No halos, glare or starbursts were reported by 91.4%, 90.9% and 95.5% of subjects, respectively.

Prof Lawless presented another sub-analysis of the AcrySof IQ Vivity registry in 23 patients with previous myopia-correcting corneal refractive surgery and six with previous hyperopia-correcting corneal refractive surgery at least three months after surgery.7 In this analysis, both patient groups had mean best-corrected distance visual acuity (BCVA) of 20/20, along with distance-corrected intermediate visual acuity (BCDVA) of 20/25 and near visual acuity (DCNVA) or 20/32-20/40. The majority of patients* had no halos, glare, or starbursts, and 82.6% of patients with post-myopic and all with post-hyperopic refractive surgery, were satisfied with their sight after the surgery.

In another sub-analysis of the registry study⁸ by McCartney et al, the real‑world clinical visual outcomes in 66 subjects with pre-operative dry eyes and bilaterally implanted with AcrySof IQ Vivity extended depth-of-focus IOLs were evaluated, finding that:

• At the study entry visit (~three months), binocular mean logMAR (standard deviation) UCDVA was 0.026 (0.118), UCIVA 0.088 (0.132) and UCNVA 0.222 (0.150).
• Binocular mean BCDVA was -0.022 (0.082), DCIVA 0.092 (0.129) and DCNVA 0.260 (0.133).
• The majority of subjects in this cohort never or rarely needed to wear spectacles for distance or intermediate tasks (≥84.6% and ≥69.2% in bright and dim conditions, respectively).
• High levels of satisfaction were observed, with 78.4% of subjects reporting that they were satisfied with their sight.
• No halos, glare or starbursts were reported by 90.8%, 93.8% and 92.3% of these subjects, respectively.

Overall, the results demonstrated that subjects with dry eye bilaterally implanted with AcrySof Vivity IQ IOLs achieved good distance, intermediate and functional near vision.

©2022 Alcon Inc. Alcon Laboratories (Australia) Pty Ltd. AUS: 1800 224 153. Auckland, NZ. 0800 101 106. ANZ-VIV-2200107 

* No halos, glare or starbursts were reported in 91.3%, 87.0%, and 91.3% respectively in patients with previous myopia-correcting corneal refractive surgery; and 83.3%, 100%, and 100% respectively, in patients with previous hyperopia-correcting corneal refractive surgery. Victor Loh is the Head of APAC Medical Affairs at Alcon. 

Caridad Perez Vives is the International Medical Director for IOLs at Alcon. 

References 

1. Alcon Data on File, US Patent 9968440 B2, May 15, 2018. 
2. AcrySof IQ Vivity Extended Vision IOL Directions for Use. 
3. Bala C et al. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. 
4. McCabe C, Berdahl J, Reiser H, et al. Clinical Outcomes in a United States Registration Study of a Novel Extended Depth of Focus Intraocular Lens with a Nondiffractive Design. J Cataract and Refract Surg. May 2022. 
5. Lawless M, Yu-Li Chang L, Perez-Vives C. Real-World Visual Outcomes of a Novel Wavefront-shaping Presbyopia-correcting IOL in Cataract Patients. APACRS. Seoul. 11 Jun 2022. 
6. Borovik A, Flax A, Chang LY, Pérez-Vives C. Real World Visual Performance and Patient Satifiaction Outocomes of a Novel Wavefront-shaping Presbyopia-correcting Toric IOL. APACRS. Seoul. 11 Jun 2022. 
7. Lawless M, Chang LY, Pérez-Vives C. Real-world Visual Outcomes of a Novel Presbyopia-correcting IOL with Wavefront-shaping Technology Implantewd in Paitents with Previous Corneal Refractive Surgery. APACRS. Seoul. 11 Jun 2022. 
8. McCartney P, Chang LY, Pérez-Vives C. Real-World Visual Performance of a Novel Prebyopia-correcting IOL with Wavefront-shaping technology Implanted in Patients with Dry Eye. APACRS. Seoul. 11 Jun 2022.