Early Clinical Results With the First Toric Presbyopia-Correcting IOL Using Intraoperative Wavefront Aberrometer Guidance
To evaluate outcomes in astigmatic patients implanted with a toric intraocular lens designed to reduce post-op refractive cylinder and provide improved distance, intermediate, and near vision (Trulign, Bausch + Lomb) with the use of intraoperative wavefront aberrometer (ORA, WavTec) technology, in a standard of care setting.
Retrospective study of the safety and efficacy outcomes involving 40 eyes (31 subjects). Subjects included are without comorbidities with potential to affect post-op visual outcomes, and have post-op refractive targets of ±0.64D SE. All underwent standard of care cataract extraction and implantation with a Trulign intraocular lens utilizing intraoperative aberrometer (ORA) guidance and followed a minimum of 1 month. Endpoints include uncorrected visual acuities, reduction in refractive cylinder, accuracy to target, axis orientation, adverse events, and secondary surgical interventions. Contrasts and consistencies between the outcomes of this cohort and that of the published Trulign Summary of Safety and Effectiveness Data (SSED) are explored.
As a toric lens, Trulign effectively reduces post-operative refractive astigmatism, ≤0.50 D residual cylinder in 97.5% of eyes, while allowing for improved (> 20/25) uncorrected distance vision in 95%, uncorrected intermediate in 95%, and functional (≥ 20/40) uncorrected near vision in 92.5% of eyes. 95% of eyes obtained MRSE Accuracy to Target of ±1.00 D of intended, surpassing that of the B+L submission study. Stability of the lens (rotation of ≤ 5°) was demonstrated in all eyes and excellent preservation of best corrected visual acuities (100% ≥ 20/25) as a safety measure, was also demonstrated.
The Trulign Toric IOL exhibits excellent uncorrected distance, intermediate, and near vision along with exceptional rotational stability and predictability. Use of the Trulign Toric IOL can provide excellent refractive and visual outcomes in a standard of care setting with or without the use of intraoperative wavefront aberrometer technology (ORA).