A modular, 2-piece silicone intraocular lens (IOL) can provide clear functional vision performance across a range of distances with an acceptable safety profile in patients treated for cataracts, according to research published in the Journal of Cataract and Refractive Surgery. It avoids both loss of contrast sensitivity and increased dysphotopsias, according to the investigation.
The researchers conducted an exploratory, prospective, multi-center, open-label, noncomparative trial to evaluate the initial safety and effectiveness profile of the novel, anterior shape-changing optic IOL, the JuveneTM IOL (JIOL, LensGen Inc.), for the treatment of aphakia and presbyopia in patients after removal of the natural crystalline lens due to cataract.
The JIOL comprises a 2-piece silicone IOL, a base lens (a circumferential haptic and clear central optic) and a fluid lens (a clear posterior optic and flexible anterior surface filled with a proprietary silicone oil) that fits into the base lens under 3 haptic tabs.
The researchers recruited a convenience sample of patients aged 50 to 80 years with planned cataract surgery to undergo unilateral or bilateral implantation with the JIOL. Patients were required to be able to be pharmacologically dilated to at least 6.0 mm and to have good overall health with no significant eye health history. The research team measured visual acuities, defocus curves, and contrast sensitivity for all patients at 12 months postoperatively.
A total of 58 eyes of 42 patients, with a mean age of 66.9±6.6 years, underwent JIOL implantation. Of those, 16 patients received bilateral implantation of the JIOL. All patients were Hispanic.
The 12-month postoperative visit was completed for 51 of 58 (88%) eyes. The intraoperative complication rate was 1.7% (n=1; missed base lens tab). For the missed base lens tab, an IOL repositioning surgery was performed, and no subsequent issues occurred. The most frequently reported adverse events (AE) were diabetes/hypertension-related complications (n=8; 13.8%), postoperative inflammation lasting longer than 1 month (n=6; 10.3%), cystoid macular edema (n=4; 6.9%). A patient with severe diabetes complications discontinued the study (1.7%). The researchers report that all AEs resolved without sequelae by the 12-month visit.
The study shows a mean monocular logMAR corrected distance visual acuity (VA) of 0.01±0.06 logMAR, distance-corrected intermediate VA of 0.08±0.09, and distance-corrected near VA of 0.24±0.11. The monocular defocus testing demonstrated VA > 20/40 from approximately +1.00 D to -2.00 D, and the binocular defocus testing demonstrated VA >20/40 from approximately +2.00 D to -2.50D.
“Initial results with a novel design of a presbyopia-correcting IOL provides the excellent range of vision seen with other premium IOLs, while avoiding loss of contrast sensitivity and increased dysphotopsias,” researchers explain.
Limitations of the study included the convenience sample of patients, lack of a concurrent randomized control group, a relatively small, ancestrally homogenous group of patients, protocol modifications for patients’ safety, including a wide window for 12-months of data collection, and loss of some patients to follow up due to the COVID-19 pandemic.
Disclosure: This research was supported by LensGen, Inc. The study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Garg S, De Jesus MT, Laura MF, Chayet A, Barragán E, Casey P. Twelve-month clinical outcomes after implantation of a novel, modular, anterior shape-changing fluid optic intraocular lens J Cataract Refract Surg. Published online March 16, 2022. doi:10.1097/j.jcrs.0000000000000935