Cataract
Conditions
Keywords
cataract, virtual reality, multifocal intraocular lens, trifocal intraocular lens, monovision
Brief summary
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.
Detailed description
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.
Interventions
Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
Sponsors
Study design
Masking description
Patients will remain unaware of their specific study arm assignments until the completion of the study.
Intervention model description
Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
Eligibility
Inclusion criteria
* Bilateral cataract * Regular corneal astigmatism * Corneal endothelium cell count \>2000 cells/mm2 * Clear intraocular media other than cataract
Exclusion criteria
* Concomitant ocular diseases * Irregular corneal aberration * Capsular instability * Systemic disease that may affect vision * History of other intraocular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Virtual reality (VR) performance score | Pre-operation, Month3 | VR performance score measured from all VR simulations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular reading speed assessment | Pre-operation, Month3 | Reading speed assessed by the MNRead acuity chart |
| Binocular contrast sensitivity | Pre-operation, Month3 | Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart |
| Distance visual acuity | Pre-operation, Day1, Week1, Month1, Month3 | Monocular and binocular uncorrected and corrected distance visual acuity |
| Intermediate (66 cm) visual acuity | Month3 | Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity |
| Task-specific VR performance score | Pre-operation, Month3 | VR performance score measured from an individual VR simulation |
| Binocular defocus curve | Month3 | Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela \[cd\]/m2) |
| Photic phenomena | Pre-operation, Month3 | Evaluation of photic phenomena by the 30-item quality of vision questionnaire |
| Quality of life assessment | Pre-operation, Month3 | National Eye Institute 25-item Visual Function Questionnaire Rasch score |
| Near (40 cm) visual acuity | Month3 | Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity |