Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses.

PURPOSE: To evaluate the efficacy of a new visual training program for improving the visual function in patients implanted with trifocal intraocular lenses (IOLs). METHODS: Randomised placebo-controlled clinical trial enrolling 60 subjects (age, 47-75 years) undergoing cataract surgery with implantation of trifocal diffractive IOL. Home-based active visual training was prescribed immediately after surgery to all of them (20 sessions, 30 min): 31 subjects using a serious game based on Gabor patches (study group) and 29 using a placebo software (placebo group). Visual acuity, contrast sensitivity (CS), and perception of visual disturbances (QoV questionnaire) were evaluated before and after training. Likewise, in a small subgroup, resting-state functional magnetic resonance imaging (rs-fMRI) analysis was performed. RESULTS: No significant differences were found between groups in compliance time (p = 0.70). After training, only significant improvements in monocular uncorrected intermediate visual acuity were found in the study group (p ≤ 0.01), although differences between groups did not reach statistical significance (p ≥ 0.11). Likewise, significantly better binocular far CS values were found in the study group for the spatial frequencies of 6 (p = 0.01) and 12 cpd (p = 0.03). More visual symptoms of the QoV questionnaire experienced a significant change in the level of bothersomeness in the study group. Rs-fMRI revealed the presence significant changes reflecting higher functional connectivity after the training with the serious game. CONCLUSIONS: A 3-week visual training program based on the use of Gabor patches after bilateral implantation of trifocal diffractive IOLs may be beneficial for optimising the visual function, with neural changes associated suggesting an acceleration of neuroadaptation. Trial registration ClinicalTrials.gov, NCT04985097. Registered 02 August 2021, https://clinicaltrials.gov/(NCT04985097 ).

Preliminary Evaluation of the Clinical Benefit of a Novel Visual Rehabilitation Program in Patients Implanted with Trifocal Diffractive Intraocular Lenses: A Blinded Randomized Placebo-Controlled Clinical Trial.

The authors of this study evaluated the potential benefit on visual performance of a novel 3 week visual rehabilitation program based on the use of Gabor patches in patients undergoing bilateral cataract surgery with the implantation of two models of trifocal diffractive intraocular lens (IOL). A total of 30 patients were randomly assigned to two groups: a study group (15 patients) that used a videogame based on Gabor patches and a placebo group (15 patients) that used a videogame without specific stimuli for improving visual performance. No statistically significant differences between groups were found in distance, intermediate, and near post-training visual acuity (p ≥ 0.15). Significantly better distance contrast sensitivity (CS) was found for the spatial frequencies of 6 (p = 0.02) and 12 cpd (p = 0.01) in the study group. Likewise, significantly better values of near CS were found in the study group compared to the placebo group for the spatial frequency of 1.5 cpd (p = 0.02). In conclusion, a 3 week visual rehabilitation program based on the use of Gabor patches in the immediate postoperative period after the bilateral implantation of trifocal diffractive IOLs seems to be beneficial for improving both distance and near visual performance achieved with the implant.

Positional accommodative intraocular lens power error induced by the estimation of the corneal power and the effective lens position.

PURPOSE: To evaluate the predictability of the refractive correction achieved with a positional accommodating intraocular lenses (IOL) and to develop a potential optimization of it by minimizing the error associated with the keratometric estimation of the corneal power and by developing a predictive formula for the effective lens position (ELP). MATERIALS AND METHODS: Clinical data from 25 eyes of 14 patients (age range, 52-77 years) and undergoing cataract surgery with implantation of the accommodating IOL Crystalens HD (Bausch and Lomb) were retrospectively reviewed. In all cases, the calculation of an adjusted IOL power (P(IOLadj)) based on Gaussian optics considering the residual refractive error was done using a variable keratometric index value (n(kadj)) for corneal power estimation with and without using an estimation algorithm for ELP obtained by multiple regression analysis (ELP(adj)). P(IOLadj) was compared to the real IOL power implanted (P(IOLReal), calculated with the SRK-T formula) and also to the values estimated by the Haigis, HofferQ, and Holladay I formulas. RESULTS: No statistically significant differences were found between P(IOLReal) and P(IOLadj) when ELP(adj) was used (P = 0.10), with a range of agreement between calculations of 1.23 D. In contrast, P(IOLReal) was significantly higher when compared to P(IOLadj) without using ELP(adj) and also compared to the values estimated by the other formulas. CONCLUSIONS: Predictable refractive outcomes can be obtained with the accommodating IOL Crystalens HD using a variable keratometric index for corneal power estimation and by estimating ELP with an algorithm dependent on anatomical factors and age.

Error induced by the estimation of the corneal power and the effective lens position with a rotationally asymmetric refractive multifocal intraocular lens.

AIM: To evaluate the prediction error in intraocular lens (IOL) power calculation for a rotationally asymmetric refractive multifocal IOL and the impact on this error of the optimization of the keratometric estimation of the corneal power and the prediction of the effective lens position (ELP). METHODS: Retrospective study including a total of 25 eyes of 13 patients (age, 50 to 83y) with previous cataract surgery with implantation of the Lentis Mplus LS-312 IOL (Oculentis GmbH, Germany). In all cases, an adjusted IOL power (PIOLadj) was calculated based on Gaussian optics using a variable keratometric index value (nkadj) for the estimation of the corneal power (Pkadj) and on a new value for ELP (ELPadj) obtained by multiple regression analysis. This PIOLadj was compared with the IOL power implanted (PIOLReal) and the value proposed by three conventional formulas (Haigis, Hoffer Q and Holladay I). RESULTS: PIOLReal was not significantly different than PIOLadj and Holladay IOL power (P>0.05). In the Bland and Altman analysis, PIOLadj showed lower mean difference (-0.07 D) and limits of agreement (of 1.47 and -1.61 D) when compared to PIOLReal than the IOL power value obtained with the Holladay formula. Furthermore, ELPadj was significantly lower than ELP calculated with other conventional formulas (P<0.01) and was found to be dependent on axial length, anterior chamber depth and Pkadj. CONCLUSION: Refractive outcomes after cataract surgery with implantation of the multifocal IOL Lentis Mplus LS-312 can be optimized by minimizing the keratometric error and by estimating ELP using a mathematical expression dependent on anatomical factors.

Correlation of visual performance with quality of life and intraocular aberrometric profile in patients implanted with rotationally asymmetric multifocal IOLs.

PURPOSE: To examine the visual performance of a rotationally asymmetric multifocal intraocular lens (IOL) by correlating the defocus curve of the IOL-implanted eye with the intraocular aberrometric profile and impact on the quality of life. METHODS: A prospective, consecutive, case series study including 26 eyes from 13 patients aged between 50 and 83 years (mean: 65.54±7.59 years) was conducted. All patients underwent bilateral cataract surgery with implantation of a rotationally asymmetric multifocal IOL (Lentis Mplus LS-312 MF30, Oculentis GmbH). Distance and near visual acuity outcomes, intraocular aberrations, defocus curve, and quality of life (assessed using the National Eye Institute Visual Functioning Questionnaire-25) were evaluated postoperatively (mean follow-up: 6.42±2.24 months). RESULTS: A significant improvement in distance visual acuity was found postoperatively (P<.01). Mean postoperative logMAR distance-corrected near visual acuity was 0.19±0.12 (∼20/30). Corrected distance visual acuity and near visual acuity of 20/20 or better were achieved by 30.8% and 7.7% of eyes, respectively. Of all eyes, 96.2% had a postoperative addition between 0 and 1.00 diopter (D). The defocus curve showed two peaks of maximum visual acuity (0 and 3.00 D of defocus), with an acceptable range of intermediate vision. LogMAR visual acuity corresponding to near defocus was directly correlated with some higher order intraocular aberrations (r⩾0.44, P⩽.04). Some difficulties evaluated with the quality of life test correlated directly with near and intermediate visual acuity (r⩾0.50, P⩽.01). CONCLUSIONS: The Lentis Mplus multifocal IOL provides good distance, intermediate, and near visual outcomes; however, the induced intraocular aberrometric profile may limit the potential visual benefit.