PURPOSE: To evaluate the effect of residual manifest refraction spherical equivalent (MRSE) on distance-corrected near visual acuity (DCNVA), patient-reported frequency, severity, and bothersomeness of glare and halos, and satisfaction with near vision in patients implanted with enVista Full Range of Vision (FRoV) IOL.

METHODS: The data from 2 prospective, multicenter, double-masked, controlled clinical trials that evaluated the outcomes in patients undergoing implantation of a full range of vision (FRoV) enVista Envy IOL (Bausch + Lomb) was pooled (N=443) and analyzed. Patients were divided into two groups based on MRSE: (1) within ±0.25 D of emmetropia (plano), (2) outside ±0.25 D of emmetropia (non-plano). The relationship between postoperative MRSE and DCNVA was assessed using a generalized estimating effect (GEE) model. In addition, the relationships of postoperative MRSE with patient-reported frequency, severity, and bothersomeness of dysphotopsia and satisfaction with near vision were assessed.

RESULTS: Postoperatively, the mean MRSE was -0.09 ± 0.42 D. No statistically significant relationship was observed between postoperative MRSE and DCNVA (p=0.1390). The frequency, severity, and bothersomeness of halos or glare were comparable between the plano and non-plano groups (all p>0.05). The risk of poor satisfaction with near vision was higher in the non-plano group than the plano group (odds ratio =2.518); however, the p-value was not statistically significant (p=0.2717).

CONCLUSION: FRoV IOLs have low tolerance to residual MRSE; however, the present study showed that residual MRSE in patients implanted with the enVista Envy FRoV IOL had a negligible effect on the DCNVA outcomes, patient-reported frequency, severity, and bothersomeness of halo and glare, and patient satisfaction with near-vision outcomes.