Randomized Controlled Multicenter Clinical Trial of New Toric Presbyopia-Correcting IOL
Purpose
Purpose: To evaluate the safety and effectiveness of the Trulign Toric intraocular lens (IOL) (Bausch + Lomb), a new presbyopia-correcting toric IOL developed on the Crystalens IOL platform.
Methods
Methods: This prospective, multicenter, randomized clinical trial enrolled patients (n=229) undergoing routine cataract surgery with 16–27D required lens power and 0.83–2.50D predicted postoperative corneal astigmatism. Those with predicted postoperative astigmatism 0.83-1.32D were randomized to the Trulign Toric IOL (1.25D) or the non-toric accommodating control IOL (Crystalens 5.0); those with higher cylinder were implanted with the Trulign Toric 2.00D or 2.75D. Patients were followed with ophthalmic examinations up to 1 year. Outcome measures included the percent reduction in cylinder, rotational stability, and uncorrected distance, intermediate, and near visual acuity (UCDVA, UCIVA, UCNVA).
Results
Results: In the randomized cohort, the 1.25D Toric IOL provided significantly greater reduction in absolute cylinder (p<0.001) and significantly better UDVA (p=0.002) than the control IOL. Among all patients implanted with the Trulign Toric1.25D, 2.00D, or 2.75D IOL, at postoperative 4–6 months the percent reduction in absolute cylinder (expressed as a percentage of the intended reduction in cylinder) was 85.0%, mean monocular UCDVA, UCIVA, and UNCNVA were 20/25, 20/20, and 20/40, respectively, and the rotation of the Toric IOL from implantation was ≤5° in 96.1% of eyes. All safety endpoints were met.
Conclusion
Conclusion: The Trulign Toric IOL is safe and effective in reducing the effects of preoperative corneal astigmatism in patients undergoing cataract extraction and IOL placement. The lens provides excellent intermediate and distance vision and functional near vision, and it demonstrates excellent rotational stability.