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).Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. Research action was co-financed by the FEDER Fund through the OPTiTRAIN project (EXP 00106153/IDI-20180123) leaded by Proconsi SL within the framework of the PID (“Proyectos de Investigación y Desarrollo”) of the CDTI (Centro para el Desarrollo Tecnológico Industrial, Ministry of Economy and Competitiveness of Spain). The author David P Piñero has been supported by the Ministry of Economy, Industry and Competitiveness of Spain within the program Ramón y Cajal, RYC-2016-20471. The author Álvaro Planchuelo-Gómez has been supported by the European Union (NextGenerationEU)
