Applying Virtual Reality to Compare Visual Performance Following Bilateral Implantation of TECNIS Synergy vs TECNIS Monofocal Intraocular Lens With Monovision in Patients With Cataract: A Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- The University of Hong Kong
- Enrollment
- 114
- Primary Endpoint
- Overall Virtual reality (VR) performance score
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Professor Christopher K.S. Leung
Clinical Professor
The University of Hong Kong
Eligibility Criteria
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
Outcomes
Primary Outcomes
Overall Virtual reality (VR) performance score
Time Frame: Pre-operation, Month3
VR performance score measured from all VR simulations
Secondary Outcomes
- Binocular reading speed assessment(Pre-operation, Month3)
- Intermediate (66 cm) visual acuity(Month3)
- Task-specific VR performance score(Pre-operation, Month3)
- Binocular contrast sensitivity(Pre-operation, Month3)
- Near (40 cm) visual acuity(Month3)
- Distance visual acuity(Pre-operation, Day1, Week1, Month1, Month3)
- Binocular defocus curve(Month3)
- Photic phenomena(Pre-operation, Month3)
- Quality of life assessment(Pre-operation, Month3)