Assessment of Visual Performance With Virtual Reality After Cataract Surgery
- Conditions
- Cataract
- Interventions
- Procedure: cataract surgery with implantation of intraocular lens
- Registration Number
- NCT06015334
- Lead Sponsor
- The University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 114
- Bilateral cataract
- Regular corneal astigmatism
- Corneal endothelium cell count >2000 cells/mm2
- Clear intraocular media other than cataract
- Concomitant ocular diseases
- Irregular corneal aberration
- Capsular instability
- Systemic disease that may affect vision
- History of other intraocular surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bilateral monofocal intraocular lens implantation with monovision cataract surgery with implantation of intraocular lens Patients will receive bilateral implantation of TECNIS monofocal intraocular lens Bilateral implantation of trifocal intraocular lens cataract surgery with implantation of intraocular lens Patients will receive bilateral implantation of TECNIS Synergy intraocular lens
- Primary Outcome Measures
Name Time Method Overall Virtual reality (VR) performance score Pre-operation, Month3 VR performance score measured from all VR simulations
- Secondary Outcome Measures
Name Time Method Binocular reading speed assessment Pre-operation, Month3 Reading speed assessed by the MNRead acuity chart
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 contrast sensitivity Pre-operation, Month3 Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
Near (40 cm) visual acuity Month3 Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity
Distance visual acuity Pre-operation, Day1, Week1, Month1, Month3 Monocular and binocular uncorrected and corrected distance visual acuity
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