Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT06015334
Status:
UNKNOWN
Last Update Posted:
2023-08-29
First Post:
2023-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Visual Performance With Virtual Reality After Cataract Surgery
Sponsor:
The University of Hong Kong
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: