Grail Study shows refractive stability of Juvene IOL

Digital Edition, Ophthalmology Times: October 1, 2021, Volume 46, Issue 16

Eric Donnenfeld, MD, presents results of the year-long Grail Study demonstrating the safety and performance of the Juvene IOL from LensGen Inc.

Updated Sept. 29, 2021

The Juvene IOL (LensGen Inc.) is a new modular, shape-changing, fluid optic IOL designed to behave like the natural crystalline lens.

Twelve-month results from the "Grail" Study showed “desirable” visual outcomes and safety, according to Eric D. Donnenfeld, MD, a clinical professor in the Department of Ophthalmology at the New York University Grossman School of Medicine in New York, and a founding partner of Ophthalmic Consultants of Long Island in Garden City, New York.

This IOL has 2 components, Donnenfeld explained: a base lens that is supported by capsule-filling, circumferential haptics, and a fluid lens that fits in the base lens and facilitates uninterrupted vision at all distances.

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The "Grail" investigators, led by Donnenfeld, conducted an exploratory study of the Juvene IOL in which patients underwent small-incision cataract surgery followed by IOL implantation.

The primary outcomes evaluated were the best-corrected distance visual acuity (CDVA), distance-corrected intermediate VA (DCIVA), distance-corrected near (DCNVA), and defocus curves.

Results
Forty-two patients (58 eyes; 27 women; mean age, 66.9 years) received the Juvene IOL and were followed for 12 months.

Twelve-month data were available for 51 eyes. Seven patients were lost to follow-up, i.e., 5 did not return to the clinic because of the pandemic and 2 because of adverse events that were not related to the IOL.

Donnenfeld noted that at 12 months the mean monocular CDVA, DCIVA, and DCNVA, respectively, were 20/20 (range, –0.01 to 0.02), 20/25+ (range, 0.05-0.10), and 20/32-2 (range, 0.21-0.27), the last of which was equivalent to a Jaeger score of 2 (J2).

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The binocular CDVA, DCIVA, and DCNVA at the same time point, respectively, were 20/20+ (range, -0.05-0.02), 20/20- (range, 0.00-0.08), and 20/32+ (range, 0.11-0.24), the last of which also was equivalent to J2.

The monocular defocus curve VAs in 51 eyes at 12 months at distance, intermediate, and near, respectively, were 20/20, 20/32, and near 20/40-, the last of which was J3. The VA exceeded 20/40 from approximately +1.50 to -2.00 diopters, Donnenfeld reported.

The respective binocular defocus curve VAs in the 14 patients evaluated at 12 months were 20/20+. 20/25-2, and 20/40+2. The VA exceeded 20/40 from about +2.00 to -2.5 diopters.

Next steps
According to Donnenfeld, the patients will be evaluated at 24 and 36 months postoperatively.

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Thus far, 10 eyes have been examined at the 24-month time point. Dr. Donnenfeld reported that the mean VA outcomes were almost identical to the full cohort at 12 months; the respective VA measurements were 20/16-1, 20/25, and 20/40+2. The defocus curves were the same.

Donnenfeld noted that the findings from the Grail Study demonstrated desirable visual outcomes and safety.

“The 12- and 24-month data confirmed the refractive stability of the Juvene IOL,” he concluded. “In addition, the accommodative amplitude was maintained out to 24 months postoperatively.”

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Eric D. Donnenfeld, MD
E: ericdonnenfeld@gmail.com
This article is adapted from Donnenfeld’s presentation at the American Society of Cataract and Refractive Surgery 2021 annual meeting in Las Vegas, Nevada. He is on the scientific advisory board of LensGen, Inc.

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