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

ABSTRACT

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) (AptheraTM, Bausch & Lomb, Inc). SETTING: 21 investigational sites in the United States. DESIGN: Prospective, multi-center, open-label, parallel-group, non-randomized, examiner-masked, one-year clinical study. METHODS: Included patients had cataract and ≤1.5D preoperative corneal astigmatism. Patients received either the SA IOL in one eye targeted to -0.75D 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 0.82D additional binocular DOF versus the Control Group (n=110), and SA IOL eyes achieved 0.91D 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. Additionally, SA IOL eyes with higher (1.0-1.5D) versus lower (<1.0D) preoperative corneal astigmatism achieved equivalent monocular uncorrected VAs. CONCLUSIONS: The SA IOL provides increased DOF versus monofocal/monofocal toric IOLs and consistent monocular and binocular vision across several postoperative MRSEs and up to 1.5D of preoperative corneal astigmatism, giving patients with cataract and mild astigmatism the potential for an extended range of vision and reliable visual outcomes.