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.

Clinical outcomes after bilateral implantation of an apodized +3.0 D toric diffractive multifocal intraocular lens.

PURPOSE: To assess visual outcomes after bilateral implantation of an apodized +3.0 diopter (D) addition power toric diffractive multifocal intraocular lens (IOL). SETTING: Five study sites in Europe and South America. DESIGN: Cohort study. METHODS: Patients had bilateral implantation of the AcrySof(®) IQ ReSTOR(®)+3.0 D toric multifocal IOL. Inclusion criteria were age from 21 to 70 years, need for bilateral cataract extraction or refractive lens exchange, and regular corneal astigmatism from 0.75 to 2.5 D. Six-month evaluations included spherical equivalent (SE), refractive and corneal cylinder, visual acuity at various distances, defocus testing, reading speed, and IOL rotation. RESULTS: Forty-four of 49 patients completed the 6-month visit. The mean SE (88 eyes) was 0.09 D ± 0.49 (SD) at 6 months (± 1.00 D in 95.2%). The mean refractive cylinder decreased from 1.07 ± 0.71 D to 0.33 ± 0.44 D (≤ 0.50 D in 78.6% and ≤ 1.00 D in 92.9%). The mean binocular uncorrected visual acuity was 0.04 ± 0.08 logMAR at preferred near (≈ 39 cm), 0.07 ± 0.09 logMAR at 40 cm, 0.09 ± 0.11 logMAR at 60 cm, and 0.05 ± 0.10 logMAR at 4 m. The mean corrected reading speed increased from 125.43 ± 33.58 words per minute (wpm) to 132.68 ± 23.69 wpm. The mean IOL rotation was 2.20 ± 4.34 degrees. CONCLUSION: Six months after implantation of the toric multifocal IOL, patients had significantly reduced SE and refractive cylinder, good visual acuity across distances, increased reading speed, and minimal IOL rotation.

Subjective outcomes after bilateral implantation of an apodized diffractive +3.0 D multifocal toric IOL in a prospective clinical study.

PURPOSE: To assess subjective outcomes after bilateral implantation of an aspheric apodized diffractive +3.0 diopter (D) multifocal toric intraocular lens (IOL). METHODS: This was a prospective, single-arm, 6-month study conducted at five study sites in Europe and South America. Forty-nine patients requiring bilateral cataract extraction or refractive lens exchange and IOL implantation in both eyes with preoperative regular corneal astigmatism of 0.75 D or greater and 2.5 D or less received bilateral AcrySof ReSTOR +3.0 D toric IOLs (Models SND1T3, SND1T4, or SND1T5; Alcon Laboratories, Inc., Fort Worth, TX). Subjective questionnaires were administered preoperatively and 6 months postoperatively. RESULTS: Patient subjective experience with visual tasks at all distances improved from the preoperative visit to the 6-month visit. At the 6-month visit, 90% (36 of 40) of respondents reported complete freedom from corrective wear compared with 14% (6 of 43) pre-operatively. On a scale of 0 (worst) to 10 (best), the mean score that patients rated their uncorrected vision was 7.9 ± 1.9 at 6 months (n = 37) compared with 3.6 ± 2.0 at the preoperative visit (n = 38). CONCLUSIONS: Six months following bilateral implantation of the AcrySof ReSTOR +3.0 D toric IOL revealed improved subjective experience, increased spectacle freedom, and higher satisfaction when compared with the preoperative baseline.