Assessment of Visual Performance With Virtual Reality After Cataract Surgery

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Cataract

Treatments: Procedure: cataract surgery with implantation of intraocular lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06015334

H022_Protocol_VR Cataract

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Bilateral implantation of trifocal intraocular lens

Active Comparator group

Description:

Patients will receive bilateral implantation of TECNIS Synergy intraocular lens

Treatment:

Procedure: cataract surgery with implantation of intraocular lens

Bilateral monofocal intraocular lens implantation with monovision

Active Comparator group

Description:

Patients will receive bilateral implantation of TECNIS monofocal intraocular lens

Treatment:

Procedure: cataract surgery with implantation of intraocular lens