Evaluating the small aperture intraocular lens: depth of focus and the role of refraction and preoperative corneal astigmatism in visual performance.

PURPOSE: To evaluate depth of focus (DOF) and visual acuities (VAs) by manifest refractive spherical equivalent (MRSE) and degree of preoperative corneal astigmatism with the IC-8 small aperture intraocular lens (SA IOL) (Apthera).

SETTING

21 investigational sites in the United States.

DESIGN

Prospective, multicenter, open-label, parallel-group, nonrandomized, examiner-masked, 1-year clinical study.

METHODS

Included patients had cataract and ≤1.5 diopters (D) preoperative corneal astigmatism. Patients received either the SA IOL in 1 eye targeted to -0.75 D and a monofocal or monofocal toric IOL in the other targeted to plano (SA IOL group) or bilateral monofocal/monofocal toric IOLs targeted to plano (control group). Monocular and binocular assessments included defocus curves and uncorrected VAs (distance, intermediate, and near) by postoperative MRSE; monocular VAs were assessed by degree of preoperative corneal astigmatism.

RESULTS

The SA IOL group (n = 343) achieved 0.82 D additional binocular DOF vs the control group (n = 110), and SA IOL eyes achieved 0.91 D additional monocular DOF over fellow eyes. Across all MRSEs, the SA IOL group achieved monocular uncorrected VAs of 20/40 or better and binocular uncorrected VAs of 20/32 or better across all distances. In addition, SA IOL eyes with higher (1.0-1.5 D) vs lower (<1.0 D) preoperative corneal astigmatism achieved equivalent monocular uncorrected VAs.

CONCLUSIONS

The SA IOL provides increased DOF vs monofocal/monofocal toric IOLs and consistent monocular and binocular vision across several postoperative MRSEs and up to 1.5 D of preoperative corneal astigmatism, giving patients with cataract and mild astigmatism the potential for an extended range of vision and reliable visual outcomes.