New Toric Posterior Chamber IOL for Reduction of Residual Astigmatism Following Phacoemulsification
Narrative Responses:
Purpose
To evaluate the safety and efficacy of the TRULIGN Toric IOL (Models AT50T/ AT52T) in providing near, intermediate, and distance vision, as well as decreasing the effects of preoperative corneal astigmatism in subjects undergoing cataract extraction and IOL placement.
Methods
Prospective, monocular study of 229 eyes randomized to the toric IOL or a control lens (Crystalens AT). Postoperatively, subjects received a complete ophthalmic examination at regular intervals per the study visit schedule (up to 330-420 days or until rotational stability was achieved). Rotational stability, using photographic assessment, was performed by an independent reading center at Day 0 (Operative Day) and at Days 30-60, 120-180, 245-301, and Days 330-420. The lens was considered stable when 90% of the eyes showed axial rotational stability < 5° between consecutive scheduled visits at least 3 months apart, with stability being achieved at the latter of the 2 consecutive visits.
Results
The toric IOL provided a mean percent reduction in absolute cylinder of 85.0% and the mean reduction was greater in eyes implanted with the toric 1.25 D IOL compared with eyes implanted with control (79.9% vs. 46.5%, respectively, P<.001). Ninety-five percent of all eyes with the toric lens reached, within one diopter, the intended reduction in cylinder at the final evaluation. The toric IOL also provided a high degree of stability: 96.1% of all toric eyes had ≤ 5○ of rotation between two consecutive visits. BCDVA was 20/40 or better in the majority of toric eyes.
Conclusion
The TRULIGN Toric IOL is safe and reduces the effects of preoperative corneal astigmatism on postoperative refraction with improved distance, intermediate, and functional near vision, while demonstrating excellent rotational stability.