The Grail study finds the device can offer positive outcomes for patients.
Reviewed by Sumit Garg, MD
The Juvene IOL (LensGen, Inc) for presbyopia provided good outcomes to patients with a full range of visual acuity (VA) from distance to near for up to 24 months after implantation in the Grail study.
The Juvene IOL is a fluid-filled curvature-changing lens that has 2 components: a base lens with capsule-filling, circumferential haptics and a shape-changing fluid optic that fits into the base lens and provides incremental refractive power for a full, continuous range of vision, according to Sumit Garg, MD, vice chair of clinical ophthalmology, medical director and a professor in Cataract, Refractive, External Disease and Corneal Surgery at the Gavin Herbert Eye Institute at University of California, Irvine.
In this trial, the investigators measured the manifest refractions, best-corrected distance visual acuity, distance-corrected intermediate vision (DCIVA) at 66 cm, the distance-corrected near vision (DCNVA) at 40 cm VAs, and distance-corrected defocus curves using the M&S Technologies Clinical Trial Suite in photopic lighting. A total of 58 eyes of 42 patients were implanted with the IOL in the Grail study; 27 patients completed the 2-year evaluation. Many did not undergo evaluations because of the pandemic.
The mean monocular DCVA was 20/20, the DCIVA was 20/25, and the DCNVA was 20/40. The binocular VAs improved across all distances for all patients, Garg explained.
“It was notable that the broad monocular defocus curve showed 3.5 D of usable vision above 20/40, which was comparable to that achieved with the high-quality Vivity IOL [Alcon]. Binocular summation showed 4.5 D of usable vision at 20/40 or better,” he said.
Importantly, results demonstrated the long-term stability of the vision. “From 12 months to 24 months, there was no change seen in the effect of the IOL,” he said. Additionally, contrast vision was similar to that of a TECNIS Monofocal IOL with very high patient satisfaction of visual quality and range.
“Implantation of the Juvene IOL provided good outcomes across the full visual range out to 2 years in the Grail study,” Garg said. “The visual improvements remained stable over time.”
Sumit Garg, MD
This article was adapted from Garg’s presentation at the 2022 American Society of Cataract and Refractive Surgery Annual Meeting in Washington, DC. He is a member of the medical advisory board to LensGen, Inc.