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Assessment of Visual Performance With Virtual Reality After Cataract Surgery

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06015334
Enrollment
114
Registered
2023-08-29
Start date
2023-10-01
Completion date
2024-09-30
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

cataract, virtual reality, multifocal intraocular lens, trifocal intraocular lens, monovision

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.

Interventions

PROCEDUREcataract surgery with implantation of intraocular lens

Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.

Sponsors

Janssen, LP
CollaboratorINDUSTRY
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients will remain unaware of their specific study arm assignments until the completion of the study.

Intervention model description

Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Virtual reality (VR) performance scorePre-operation, Month3VR performance score measured from all VR simulations

Secondary

MeasureTime frameDescription
Binocular reading speed assessmentPre-operation, Month3Reading speed assessed by the MNRead acuity chart
Binocular contrast sensitivityPre-operation, Month3Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
Distance visual acuityPre-operation, Day1, Week1, Month1, Month3Monocular and binocular uncorrected and corrected distance visual acuity
Intermediate (66 cm) visual acuityMonth3Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity
Task-specific VR performance scorePre-operation, Month3VR performance score measured from an individual VR simulation
Binocular defocus curveMonth3Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela \[cd\]/m2)
Photic phenomenaPre-operation, Month3Evaluation of photic phenomena by the 30-item quality of vision questionnaire
Quality of life assessmentPre-operation, Month3National Eye Institute 25-item Visual Function Questionnaire Rasch score
Near (40 cm) visual acuityMonth3Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity

Contacts

Primary ContactChristopherAnita Yau
anitayky@hku.hk39102673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026