The proposed randomized clinical trial aims to compare visual performance, measured using VR simulations, in cataract patients implanted either with bilateral trifocal IOL or bilateral monofocal IOL with monovision. The hypothesis is that patients implanted with trifocal IOL would exhibit superior visual performance, in both daytime and nighttime conditions, compared to those with a monofocal IOL with monovision.
Cataract surgery provides an opportunity to restore the quality of life by improving vision. While monofocal intraocular lenses (IOLs) implantation with monovision has been a common approach for cataract surgery, it may result in limited clarity at the intermediate distance and reduced depth perception. The advent of multifocal IOLs has expanded the possibilities, potentially offering increased visual performance in different ranges of vision. However, the benefits of multifocal IOLs in everyday activities are not fully understood due to the lack of task-based investigations. To address this gap, a virtual reality-based approach is proposed to simulate daily activities and assess visual performance. This innovative method can provide insights into how multifocal IOLs enhance activities requiring good binocular vision at varying distances, a capability monofocal IOLs may lack. A randomized clinical trial is suggested to compare the TECNIS Synergy multi-focal IOL with the TECNIS monofocal IOL in monovision. Unlike its bifocal predecessors, the TECNIS Synergy IOL is trifocal, providing clear vision at near, intermediate, and far distances. The hypothesis is that patients implanted with the TECNIS Synergy IOL will demonstrate superior visual performance in simulated day and night conditions compared to those implanted with monofocal IOLs and monovision.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
Overall Virtual reality (VR) performance score
VR performance score measured from all VR simulations
Time frame: Pre-operation, Month3
Task-specific VR performance score
VR performance score measured from an individual VR simulation
Time frame: Pre-operation, Month3
Binocular reading speed assessment
Reading speed assessed by the MNRead acuity chart
Time frame: Pre-operation, Month3
Binocular contrast sensitivity
Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
Time frame: Pre-operation, Month3
Distance visual acuity
Monocular and binocular uncorrected and corrected distance visual acuity
Time frame: Pre-operation, Day1, Week1, Month1, Month3
Intermediate (66 cm) visual acuity
Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity
Time frame: Month3
Near (40 cm) visual acuity
Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity
Time frame: Month3
Binocular defocus curve
Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela \[cd\]/m2)
Time frame: Month3
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Photic phenomena
Evaluation of photic phenomena by the 30-item quality of vision questionnaire
Time frame: Pre-operation, Month3
Quality of life assessment
National Eye Institute 25-item Visual Function Questionnaire Rasch score
Time frame: Pre-operation, Month3