Comparing visual outcomes in matched patients receiving a low cylinder power toric IOL or a non-toric IOL

To evaluate visual and refractive outcomes of the Alcon Clareon^® T2 toric IOL (1.00 D cylinder at the IOL plane, ~ 0.65 D at the corneal plane) versus the Clareon^® non-toric IOL.

Single ophthalmology clinic in Haugesund, Norway.

This was an exploratory single site randomized, unmasked, prospective clinical trial. The study was registered with clinicaltrials.gov (NCT06717607, registered retrospectively on 12/5/2024). Patients presenting for routine cataract surgery in one or both eyes, where at least one eye qualified for implantation of the T2 lens, were enrolled. Qualifying eyes were randomized to a T2 lens or a non-toric lens. Subjects were evaluated monocularly before surgery and three months postoperative. Testing included uncorrected and corrected distance visual acuity (VA), the manifest refraction, low contrast VA (photopic and mesopic, with and without glare) and contrast sensitivity (photopic and mesopic). These latter two tests were conducted with the distance correction in place.

Fifty eyes of 43 subjects were successfully enrolled from 6/2022 to 5/2024, including 30 eyes (25 subjects) randomized to the toric IOL and 20 eyes (18 subjects) to the non-toric IOL. Analysis included all enrolled eyes. Subjects were matched for age (p = 0.59), sex (p = 0.30), mean keratometry (p = 0.44), anterior corneal astigmatism (p = 0.97), axial length (p = 0.12) and anterior chamber depth (p = 0.40). Postoperatively, there was no statistically significant difference in the spherical equivalent refraction (p = 0.08). Residual refractive cylinder was statistically significantly lower in the T2 group (0.22 ± 0.22 D vs. 0.59 ± 0.28 D, p < 0.01). The T2 group also had statistically significantly better uncorrected logMAR distance VA than the non-toric group (0.00 ± 0.08 vs. 0.09 ± 0.13, p < 0.01). Low contrast VA was not statistically significantly different between the two lens types under any test condition (p = 0.49 or higher in all cases), nor were photopic or mesopic contrast sensitivity (p = 0.71 and p = 0.63, respectively).

Use of the low cylinder power toric IOL provided significantly better UDVA, with no significant differences in distance-corrected contrast sensitivity or low contrast acuity. The achieved cylinder correction was consistent with expectations.

https://clinicaltrials.gov/, identifier NCT06717607.