Purpose: To assess efficacy, safety, predictability, and stability after clear lens extraction (CLE) with multifocal diffractive intraocular lens (IOL) implantation.
Design: Prospective, nonrandomized, masked observational case series (self-controlled).
Participants: Two hundred twenty-four eyes of 112 consecutive patients after CLE with bilateral AcrySof ReSTOR Natural IOL implantation. Eyes were divided into myopic (mean spherical equivalent [SE], -6.01+/-2.71 diopters [D]) and hyperopic (mean SE, +3.86+/-2.52 D) groups.
Methods: Monocular and binocular uncorrected distance visual acuity (VA), best-corrected distance VA, uncorrected distance near VA, and best distance-corrected near VA were recorded preoperatively and 6 months after surgery.
Main outcomes measures: Efficacy, safety, predictability, and stability.
Results: At 6 months postoperatively, uncorrected distance VA was 20/25 or better in 100% of the eyes. Efficacy indexes were 0.97 for myopic and 0.96 for hyperopic patients. No eye lost > or =2 lines of best-corrected distance VA; for the myopic group, 10 eyes gained 1 line, and 10 eyes gained > or =2 lines; for the hyperopic group, 20 eyes gained 1 line, and 15 eyes gained > or =2 lines. Safety indexes were 1.05 for myopic and 1.02 for hyperopic patients. All eyes were within +/-1.00 D of the desired refraction. No eye lost >2 lines of best distance-corrected near VA; for the myopic group, 10 eyes lost 1 or 2 lines, 15 eyes gained 1 line, and 5 eyes gained 2 lines; for the hyperopic group, 8 eyes lost 1 or 2 lines, 20 eyes gained 1 line, and 16 eyes gained 2 lines. Safety indexes at near were 1.05 for myopic and 1.11 for hyperopic patients. Uncorrected distance near VA was better for hyperopic than myopic patients (0.95+/-0.08 vs. 0.88+/-0.15). Efficacy indexes at near were 1.03 for myopic and 1.10 for hyperopic patients.
Conclusions: Clear lens extraction with multifocal IOL implantation is an effective procedure for correcting ametropia and presbyopia. Safety and efficacy indexes at distance were comparable in myopic and hyperopic patients. However, at near, both indexes were larger for hyperopic patients.