GRAIL Study Supports Modular, Shape-Changing IOL

intraocular lens insertion
A study shows the 1 year stability of a fluid-filled intraocular lens that changes power.

This article is part of Ophthalmology Advisor’s conference coverage from the 2021 meeting of the American Academy of Ophthalmology, held in New Orleans from November 12 to 15, 2021. The team at Ophthalmology Advisor will be reporting on a variety of the research presented by the ophthalmology experts at the AAO. Check back for more from the AAO 2021 Meeting.

 

Results from the GRAIL Study show that the Juvene (LensGen) intraocular lens’s (IOL) long-term results indicate that “good vision is achieved from distance through near, and that patients remain refractively stable out to 1 year,” according to the presenters. The Juvene IOL has a base component with a fixed power optic that fills the entire capsular bag — anterior and posterior. The device has a fluid-filled anterior lens that changes power when the ciliary body contracts and relaxes. 

Investigators, including Uday Devgan, MD, Eric Donnenfeld, MD, and Kerry Solomon, MD, presented the GRAIL Study findings at the American Academy of Ophthalmology 2021 meeting, held in New Orleans from November 12-15.

The report shows that, 1 year after implantation, 55 eyes were evaluated through manifest refractions, visual acuities (VA), and defocus curves. Out of the 38 patients in the study, 16 patients were implanted bilaterally, while the remainder were implanted monocularly. 

The results of this study show that mean monocular logMAR best corrected distance visual acuity was 0.01 (20/20). The mean monocular logMAR distance-corrected intermediate visual acuity was 0.08 (20/25+1). Additionally, the mean monocular logMAR distance-corrected near visual acuity was 0.24 (20/32-2).  Monocular defocus curves show VA better than 20/40 from +1.00 D through −2.00 D of defocus. 

For patients implanted bilaterally, mean logMAR best corrected distance visual acuity was -0.01 (20/20), while the mean logMAR distance-corrected intermediate visual acuity was 0.05 (20/20-2). The mean logMAR distance-corrected near visual acuity was 0.18 (20/32+1). Defocus curves show VA better than 20/40 from +2.00 D through -2.50 D.

For both monocular and bilateral implantation, patients did not exhibit any difference in manifest refraction spherical equivalent (MRSE) after approximately 3 months.

Disclosure: One presenter declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.  

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Reference

Chayet AS, Devgan U, Donnenfeld ED, Solomon KD, Barragan E, Garg S. GRAIL Study final refractive outcomes and stability of a modular, shape-changing IOL. Paper presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PA023.