Novel Presbyopia Correcting IOL

Efficacy and safety results from pivotal trial show the non-diffractive EDOF lens meets its design goals. Cheryl Guttman Krader reports from ASCRS in Las Vegas, USA

The novel, non-diffractive extended depth of focus Vivity IOL (Alcon) provided superior distance-corrected intermediate and near vision, a greater range of vision, and non-inferior best-corrected distance vision in a recent multicentre trial, reports Cathleen McCabe MD.

Dr McCabe was the investigator at one of the 11 centres participating in the pivotal trial that led to US FDA approval of the Vivity IOL. “Having a non-diffractive EDOF lens that does not split light, provides excellent quality of vision with a visual disturbance profile equal to the monofocal lens, and is built on the rotational stability of the AcrySof platform has allowed me to expand the number of patients I can offer a presbyopia-correcting solution to at the time of cataract surgery,” she told EuroTimes.

“Now, patients who I would consider borderline candidates for a diffractive presbyopia-correcting IOL can be given the opportunity to experience a range of vision independent of glasses. Such patients include those with a few drusen or retinal pigment epithelium changes, a small non-foveal-affecting epiretinal membrane, borderline thinning, early changes in the nerve fibre layer, concern about a risk of glare, or haloes postoperatively.”

The Vivity IOL design includes a novel “X-Wave” wavefrontshaping technology that aims to provide a continuous extended range of vision with a visual disturbance profile similar to the aspheric monofocal AcrySof IQ SN60WF IOL.

“Built on the AcrySof platform, the Vivity looks like the SN60WF—but the central 2.2 mm of the Vivity optic stretches and shifts the wavefront without light splitting to provide an extended focal range rather than multiple focal points,” Dr McCabe explained.

Point spread function analyses show the area of precisely focused light for the monofocal SN60WF lens is around distance but extends to the intermediate range and includes some functional near vision for the Vivity lens, she added.

PIVOTAL TRIAL PERFORMANCE The pivotal trial randomised 221 cataract patients to bilateral implantation with the Vivity IOL or the AcrySof IQ monofocal IOL. Refractive predictability was good in both study groups. Among first implanted eyes, the rate of achieved MRSE ≤0.5D of emmetropia was 91.6% for the Vivity IOL and 86.5% for the aspheric monofocal IOL.

The study met its key endpoints chosen to demonstrate the Vivity IOL fulfilled American National Standards Institute criteria for EDOF IOLs. In testing conducted six months postoperatively, the Vivity IOL demonstrated a greater range of monocular defocus compared to the aspheric monofocal IOL. In addition, the Vivity IOL was statistically superior to the control lens in mean photopic monocular distance-corrected intermediate visual acuity (DCIVA) and non-inferior for best-corrected distance vision.

Additional analyses showed that 72.9% of first eyes implanted with the Vivity IOL vs 25.2% of first eyes receiving the aspheric monofocal IOL achieved monocular DCIVA of 0.2 logMAR or better. Mean photopic monocular distance corrected near visual acuity measured at 40 cm was also statistically superior in eyes implanted with the Vivity IOL compared to the control group.

Patient experiences with visual disturbances were collected using the validated Questionnaire for Visual Disturbances (QUVID). At six months, no patients reported severe glare and only 0.9% in both groups reported severe halos. The severe starburst rates were 3.8% for the Vivity IOL and 2.7% for the monocular lens.

“Most patients in both groups indicated being ‘not bothered at all’ by haloes, starbursts, or glare, and there were no statistically significant differences between groups for these outcomes,” Dr McCabe said.

Responding to a question about contrast sensitivity results, Dr McCabe said data from monocular testing in the pivotal study showed the Vivity IOL associated with a meaningful decrease in contrast sensitivity compared with the monofocal IOL at only a single spatial frequency.

“It is hard to know what this difference means clinically, but as a surrogate measure for understanding the relevance, the percentages of patients who reported not experiencing or being bothered by blurred or hazy vision were the same or higher in the Vivity group compared to the control,” she explained. “In addition, patients in the Vivity group reported having ‘good’ or ‘very good’ vision in both bright and dim light at the same rate or at a higher frequency than the patients implanted with the monofocal lens.

“These data correspond with the experience of my patients implanted with the Vivity lens who report being happy with their quality of vision and not bothered at all by blur, haze, or visual disturbances.”

“Now, patients who I would consider borderline candidates for a diffractive presbyopia-correcting IOL can be given the opportunity to experience a range of vision independent of glasses.”

Cathleen McCabe MD is the Medical Director, The Eye Associates, Bradenton, Florida, USA cmccabe13@hotmail.com