Clinical trial NCT06015334: Assessment of Visual Performance With Virtual Reality After Cataract Surgery
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Keywords: cataract
virtual reality
multifocal intraocular lens
trifocal intraocular lens
monovision
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2023-08-29
Enrollment: 114
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Virtual reality (VR) performance score
timeFrame: Pre-operation, Month3
Secondary outcomes:
measure: Task-specific VR performance score
timeFrame: Pre-operation, Month3
measure: Binocular reading speed assessment
timeFrame: Pre-operation, Month3
measure: Binocular contrast sensitivity
timeFrame: Pre-operation, Month3
measure: Distance visual acuity
timeFrame: Pre-operation, Day1, Week1, Month1, Month3
measure: Intermediate (66 cm) visual acuity
timeFrame: Month3
measure: Near (40 cm) visual acuity
timeFrame: Month3
measure: Binocular defocus curve
timeFrame: Month3
measure: Photic phenomena
timeFrame: Pre-operation, Month3
measure: Quality of life assessment
timeFrame: Pre-operation, Month3
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Christopher Leung, MD, MB ChB
role: PRINCIPAL_INVESTIGATOR
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