An interventional study of cataract surgery with implantation of intraocular lens in Cataract, sponsored by The University of Hong Kong. Not yet recruiting. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 114 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive bilateral implantation of TECNIS Synergy intraocular lens
Procedure: cataract surgery with implantation of intraocular lens
Patients will receive bilateral implantation of TECNIS monofocal intraocular lens
Procedure: cataract 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.
Overall Virtual reality (VR) performance score
VR performance score measured from all VR simulations
Time frame: Pre-operation, Month3
Task-specific VR performance score
VR performance score measured from an individual VR simulation
Time frame: Pre-operation, Month3
Binocular reading speed assessment
Reading speed assessed by the MNRead acuity chart
Time frame: Pre-operation, Month3
Binocular contrast sensitivity
Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
Time frame: Pre-operation, Month3
Distance visual acuity
Monocular and binocular uncorrected and corrected distance visual acuity
Time frame: Pre-operation, Day1, Week1, Month1, Month3
Intermediate (66 cm) visual acuity
Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity
Time frame: Month3
Near (40 cm) visual acuity
Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity
Time frame: Month3
Binocular defocus curve
Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela \[cd\]/m2)
Time frame: Month3
Photic phenomena
Evaluation of photic phenomena by the 30-item quality of vision questionnaire
Time frame: Pre-operation, Month3
Quality of life assessment
National Eye Institute 25-item Visual Function Questionnaire Rasch score
Time frame: Pre-operation, Month3
No study locations are listed for this record.
Plan to share: No — Our plan is focused on publishing the analyzed results of our research through peer-review, journals and conference papers. We understand the importance of patient privacy and confidentiality. Therefore, we will not share any individual patient data with any third parties.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong