Assessment of Visual Performance With Virtual Reality After Cataract Surgery

Study 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.

Official Title
-----------------
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.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: cataract surgery with implantation of intraocular lens


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral implantation of trifocal intraocular lens<br>Patients will receive bilateral implantation of TECNIS Synergy intraocular lens | Procedure: cataract surgery with implantation of intraocular lens<br>* Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.<br>|
| Active Comparator: Bilateral monofocal intraocular lens implantation with monovision<br>Patients will receive bilateral implantation of TECNIS monofocal intraocular lens | Procedure: cataract surgery with implantation of intraocular lens<br>* Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Virtual reality (VR) performance score | VR performance score measured from all VR simulations | Pre-operation, Month3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task-specific VR performance score | VR performance score measured from an individual VR simulation | Pre-operation, Month3 | 
| Binocular reading speed assessment | Reading speed assessed by the MNRead acuity chart | Pre-operation, Month3 | 
| Binocular contrast sensitivity | Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart | Pre-operation, Month3 | 
| Distance visual acuity | Monocular and binocular uncorrected and corrected distance visual acuity | Pre-operation, Day1, Week1, Month1, Month3 | 
| Intermediate (66 cm) visual acuity | Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity | Month3 | 
| Near (40 cm) visual acuity | Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity | Month3 | 
| Binocular defocus curve | Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2) | Month3 | 
| Photic phenomena | Evaluation of photic phenomena by the 30-item quality of vision questionnaire | Pre-operation, Month3 | 
| Quality of life assessment | National Eye Institute 25-item Visual Function Questionnaire Rasch score | Pre-operation, Month3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, virtual reality, multifocal intraocular lens, trifocal intraocular lens, monovision