One-Year Results for Juvene IOL

12-month data show refractive stability, promising functional outcomes. Cheryl Guttman Krader reports

One year follow-up data from the GRAIL study indicate that the modular, shape-changing Juvene® IOL (LensGen®) provides a full range of vision from distance to near with good refractive stability over the longer term.

The GRAIL study is an international, multicentre, noncomparative trial. Arturo S Chayet MD presented the 12-month results. The study analysed data from 51 (88%) of 58 implanted eyes, including 14 (88%) of 16 bilaterally implanted subjects. Mean manifest refractive spherical equivalent (MRSE) at 12 months was -0.85 D ± 1.00 D.

Dr Chayet noted all the surgeries were performed using a preliminary theoretical A-constant.

“Results have improved in a subsequent cohort of patients operated on using a refined A-constant, and I also believe there is more nuance to refract patients who have this shape-changing lens,” Dr Chayet said.

Refractions stabilised by month three. The mean absolute change from month three to month 12 was 0.38 ± 0.58 D, and there were no statistically significant differences in mean MRSE between any visits in the study.

At 12 months, monocular visual acuity with distance correction was ≥20/25 at distance for all eyes, ≥J2 at intermediate in 98% of eyes, and ≥J3 at near in 82% of eyes. In binocular testing with distance correction, all bilaterally implanted patients achieved ≥20/25 visual acuity at distance and ≥J1 at intermediate, and 92% saw ≥J3 at near.

With distance correction, the monocular defocus curve showed the Juvene IOL provided distance vision comparable to a monofocal lens, intermediate vision comparable to an extended depth of focus (EDOF) IOL, and near vision superior to the EDOF lens. The binocular defocus curve from the bilaterally implanted patients showed improved performance with binocular summation and results comparable to an EDOF IOL at intermediate and superior at near.

FUTURE PLANS Sumit “Sam” Garg MD is a member of the LensGen Scientific Advisory Board. He told EuroTimes, “The Juvene lens has the promise to deliver excellent range of vision without significant dysphotopsia, and this potential is supported by the data available so far. In addition, patient satisfaction has been excellent, with many patients achieving spectacle independence. Furthermore, with attributes that include modularity (which allows for exchange and/or upgradeability amongst other things) and filling of the capsular bag (which minimises posterior capsule opacification), the Juvene holds the opportunity for changing the current paradigm of cataract surgery.”

The Juvene IOL consists of a capsule-filling base lens and a fluid lens that fits into the base lens and has a shapechanging anterior surface. The GRAIL study used a singlesize base lens implanted through a 3.0 mm incision that researchers expect to fit at least 90% of eyes. A source from LensGen told EuroTimes different size lenses to satisfy a wider range of eyes will be pursued through a post-marketing study conducted after receipt of initial PMA approval.

LensGen recently received approval to begin enrolment in a US FDA trial. The company is planning a study for CE approval and targeting its launch in the second quarter of 2022.

Dr Chayet presented the study at the AAO21 conference in New Orleans, Louisiana, USA.

Arturo S Chayet MD is Director of the CODET Vision Institute, Tijuana, Mexico. arturo.chayet@gmail.com

Sumit Garg MD is Professor of Ophthalmology, Gavin Herbert Eye Institute, University of California, Irvine, USA. He is a scientific advisor for LensGen. gargs@hs.uci.edu

ESCRS

YOUNG OPHTHALMOLOGISTS

Contact: YO@ESCRS.org YO.ESCRS.org