Safety and Efficacy of Novel Presbyopia-Correcting Toric Silicone Posterior Chamber IOL
Narrative Responses:
Purpose
To evaluate the safety and effectiveness of the Trulign Toric IOL in adults with cataract.
Methods
Prospective, randomized, single-masked, monocular, multicentered study of 210 patients with age-related cataract, requiring lens power 16.00 diopters (D) to 27.00 D and predicted postoperative astigmatism 0.83 D to 2.50 D, were implanted with the Trulign Toric IOL (Test lens) or non-toric Crystalens accommodating IOL (Control lens). Following a baseline preoperative examination, subjects with lower toricity were randomized and stratified by site to receive either the Trulign Toric IOL (model AT50T or AT52T; Test lens) or non-toric Crystalens accommodating IOL (model AT50SE or AT52SE; Bausch & Lomb, Control lens).
Results
The Trulign Toric 1.25D group had significantly greater mean percent reduction in absolute cylinder versus the Crystalens Control group (CCG). A greater incidence of eyes in the Trulign Toric 1.25D group than the CCG had a cumulative residual cylinder of ≤ 1.00 D. Mean uncorrected distance visual acuity was statistically significantly better for Trulign Toric 1.25D (20/25) and All Trulign Toric groups (20/25) compared with the CCG (20/30). Mean monocular uncorrected vision at distance, intermediate, and near with the All Trulign Toric was 20/25, 20/22, and 20/40. There was no significant difference in incidence of study AEs compared with the FDA grid rate.
Conclusion
The Trulign Toric IOL is safe and effective in reducing the effects of preoperative corneal astigmatism and provides excellent uncorrected distance and intermediate vision and functional near vision.