A comparison of patient-reported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens

Abstract

Objective: The primary objective of this research was to compare cataract patient-reported outcomes of subjects bilaterally implanted with apodized diffractive intraocular lenses (AD-IOL) to subjects bilaterally implanted with conventional monofocal intraocular lenses (CM-IOL). A secondary objective was to establish the relationship between uncorrected visual acuity and patient-reported outcomes.

Methods: This was a prospective non-randomized, open-label clinical trial consisting of 339 patients bilaterally implanted with the AD-IOL and 156 bilaterally implanted with the CM-IOL. The outcomes of both groups were assessed 6 months postoperatively after second eye implantation. Assessed endpoints included patient-reported outcomes and visual acuity. Limitations of this study include the lack of random assignment to treatment groups and lack of masking of both the physicians and patients.

Results: AD-IOL patients demonstrated significantly better uncorrected near visual acuity (UCNVA) compared to CM-IOL patients (0.02 versus 0.41 log MAR [logarithm of the minimum angle of resolution], respectively; p < 0.0001). UCNVA was significantly correlated with nine patient-reported outcomes in the AD-IOL group and two patient-reported outcomes in the CM-IOL group. Significantly more AD-IOL patients reported spectacle independence compared to CM patients (80% versus 8% respectively; p < 0.0001). AD-IOL patients reported their vision quality as better than CM-IOL patients (p < 0.0001). AD-IOL patients were more satisfied with their daytime (p < 0.0001), nighttime (p < 0.0001), and overall (p < 0.0001) vision than CM-IOL patients. AD-IOL patients reported less trouble with their daytime (p < 0.0001) and nighttime (p = 0.0238) vision compared to CM-IOL patients. Furthermore, AD-IOL patients reported less distance vision limitation (p = 0.0282), less near vision limitation (p < 0.0001), and less social limitation (p < 0.0001) than CM-IOL patients.

Conclusions: The patient reported near vision benefits of the AD-IOL coupled with its high rate of spectacle independence significantly improved cataract patients' health-related quality-of-life, compared to a CM-IOL.