Continuing the Evolution in Presbyopia-Correcting IOL Technology

Hybrid lens delivering high rates of complete spectacle independence. Cheryl Guttman Krader reports

Amajority of patients receiving the Tecnis® Synergy™ IOL (Johnson & Johnson Vision) are spectacle-free at all distances, suggest follow-up results from a US FDA trial presented by Daniel H Chang MD.

The Tecnis Synergy IOL is a presbyopia-correcting lens with a hybrid design combining multifocal and extended depth of focus (EDOF) technologies.

Dr Chang was an investigator in the FDA trial and presented outcomes from defocus curve testing and patient-reported outcome questionnaires. He also reported clinical success using the Technis Synergy IOL since its commercial launch, highlighting a case involving his research optometrist.

“My research optometrist, Dr Laura Huggins, has been evaluating participants in clinical trials with new presbyopia-correcting technologies for years. She sees many of my surgical patients postoperatively. By age 46, Dr Huggins noticed decreased visual quality from nuclear changes and decided she was tired of glasses, so had surgery with bilateral Technis Synergy IOLs. She now has uncorrected vision of 20/15 at distance and 20/12.5+2 at near, picking letters off of the 20/10 line. She is thrilled with her vision, her full spectacle independence, and (thankfully) her surgeon!” Dr Chang reported.

DEFOCUS TESTING The US FDA clinical trial compared the Tecnis Synergy IOL with the Tecnis one-piece aspheric monofocal IOL (model ZCB00). The Synergy IOL used in the study (model ZFR00V) was not preloaded. The commercially available lens (model DFR00V) now comes preloaded in the Simplicity® injector.

Bilateral distance-corrected defocus curve results at one month showed the ZFR00V maintained at least 0.2 logMAR (20/32) visual acuity from 0.0 D through approximately -3.5 D and showed at least ~2.3 D greater range than the ZCB00. Results from monocular testing at six months were similar, with the ZFR00V maintaining 0.2 logMAR visual acuity for ~3.3 D with ~2.4 D greater range than the ZCB00.

“The Tecnis Synergy IOL does not have an add power or focal length because it is a hybrid lens. It has a range of clear focus, so patients can hold materials where they want and not where the lens dictates. Because testing is performed at 4 m, clinical defocus curves do not show the real-world near vision bolstered by an accentuated magnification effect as objects move closer than 40 cm.”

SUBJECTIVE DATA Spectacle independence was evaluated at six months. Using a stringent five-point scale to measure how often patients actually wore spectacles for far, intermediate, near, and overall vision—87.8% of patients in the Synergy group answered “none of the time” for all four conditions compared to only 3.1% of patients in the control group. When asked about whether they felt they needed glasses, at least 91% of patients in the Synergy group reported not needing glasses for far, intermediate, or near vision.

“The latter question shows that patients didn’t wear glasses because they didn’t need them,” Dr Chang explained. “This is the highest level of spectacle independence I have ever seen in a clinical trial. Considering the FDA study did not allow for correction of postoperative refractive error, real-world spectacle independence should be even higher.”

EARLY IMPRESSIONS Douglas D Koch MD—Baylor College of Medicine, Houston, Texas, USA—noted he implanted the Synergy IOL in several patients since it became commercially available and was very impressed that all patients in his limited series were spectacle independent. He added he was particularly impressed by the quality of vision at all three distances, assuming one hits the refractive target. In contrast, some patients implanted with the PanOptix® IOL (Alcon) need glasses for near because the PanOptix only focuses 25% of light for near.

Sumit Garg MD—University of California, Irvine, USA—said the patients he has implanted with the Synergy IOL are very happy with their range of vision. However, Dr Garg noted patients may not achieve their best distance vision right away and can still experience dysphotopsia.

“There has to be some compromise with any IOL that splits light. But once my patients reached their best vision, there have been essentially no complaints about quality of vision, other than modest halos or glare,” Dr Koch commented.

Dr Chang told EuroTimes that his research optometrist does note dysphotopsia symptoms but is not bothered by them and functions comfortably in all lighting conditions. “Dr Huggins knew exactly what to expect, so she is quite happy with her visual quality, range of vision, and level of dysphotopsias.” Referring to data from the US FDA trial, he noted only a few of the collected reports of optical/visual symptoms were “severe.” The highest rate of the most bothersome symptom was 5.3% for starbursts.

“The dysphotopsia results are not surprising and even expected for a lens that provides this great a range of vision and spectacle independence. The Tecnis Synergy’s OptiBlue™ chromophore and HD lathing techniques have ameliorated but not eliminated these symptoms. Appropriate preoperative and postoperative counselling is key for the successful clinical adoption of any presbyopia-correcting IOL. For higher patient satisfaction, I prefer to implant the Synergy in the non-dominant eye first. Additionally, I like to use the Synergy in combination with the new Tecnis Symfony™ OptiBlue™ IOL, a lens designed to further reduce dysphotopsias and provide the best balance of visual quality, range of vision, and dysphotopsias.”

The presentation and discussion occurred at the AAO 2021 conference in New Orleans, Louisiana, USA.

Daniel H Chang MD is in private practice in Bakersfield, California, USA. He is also a consultant and investor in Johnson & Johnson Vision. dchang@empireeyeandlaser.com Sumit Garg, MD gargs@hc.uci.edu Douglas D Koch, MD dkoch@bcm.edu