Trulign toric accommodating posterior chamber iol
To facilitate toric IOL selection and axis placement, a proprietary Toric Calculator was used to determine the appropriate Trulign Toric IOL model and axis of placement for each eye (Fig. The Trulign Toric IOL Calculator was used to calculate the predicted postoperative corneal astigmatism using preoperative keratometry, phaco/insertion incision location, and predicted magnitude of surgically induced astigmatism (SIA) inputs entered by the physician.
The calculator accounted for SIA, incision location, and the patient’s preoperative corneal astigmatism, and determined the toric IOL cylinder power needed and placement orientation to best correct the patient’s predicted postoperative corneal astigmatism.
The original FDA labeling for each of the two platforms (Crystalens and Trulign) enables near, intermediate, and distance vision without spectacles.
The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.
The data also support a percent reduction in absolute cylinder, cylinder correction accuracy, rotational stability of the lens, and improvement of UDVA following implantation of Trulign Toric IOL (Figs. All three toric powers implanted cumulatively had a 78.4% cylinder correction accuracy within 0.5 D of intended target compared with 45.1% in the control group, and 95.5% were within 1.00 D of the intended target compared with 72.1% in the control group (Fig. Rotational stability is vital in terms of final visual outcome with a toric IOL and even as little as a 4-degree misalignment or a cyclotorsion effect can cause a loss of 14% of the cylindrical correction effect, correlating to an approximate 3.3% decrease in cylinder correction per degree of rotation (Fig. Looking at all toric cohorts at 4 to 6 months postoperatively, the mean rotation was less than 2 degrees, and 96.1% of all eyes had 5 degrees or less of rotation (Fig. When comparing the pivotal trial data for Trulign Toric compared with the other two FDA-approved toric IOLs, Trulign achieved 96.1% rotational stability less than 5 degrees, whereas the Acrysof IQ monofocal toric achieved only 81.1% rotational stability less than 5 degrees, and the Tecnis monofocal toric achieved only 94.0% less than 5 degrees (Fig. By far, the Trulign Toric definitely did not any show any noninferiority compared with its two toric IOL predecessors on the U.
accommodating posterior chamber intraocular lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.
Slit lamp photographic images of as asymmetric vault are included in the Directions for Use (DFU).
Definitive causes of vaulting have not been established.
The FDA-approved IOL powers for the Crystalens AT50 AO range from 17 to 33 D (in 0.5-D increments) and 18 to 22 D (in 0.25-D increments) and for the Crystalens AT52AO range from 4 to 9 D (in 1.0-D increments) and 10 to 24 D (in 0.5-D increments) (Fig. Table 45.1 summarizes the Crystalens platforms approved since 2003; the Crystalens models AT50AO and AT52AO are the most commonly used designs as of 2015.The clinical results were obtained using an A constant of 119.0, the SRK/T formula, and immersion biometry or interferometry and manual keratometry.