- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06015334
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ChristopherAnita Yau
- Phone Number: 39102673
- Email: anitayky@hku.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bilateral implantation of trifocal intraocular lens
Patients will receive bilateral implantation of TECNIS Synergy intraocular lens
|
Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
|
Active Comparator: Bilateral monofocal intraocular lens implantation with monovision
Patients will receive bilateral implantation of TECNIS monofocal intraocular lens
|
Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Virtual reality (VR) performance score
Time Frame: Pre-operation, Month3
|
VR performance score measured from all VR simulations
|
Pre-operation, Month3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Task-specific VR performance score
Time Frame: Pre-operation, Month3
|
VR performance score measured from an individual VR simulation
|
Pre-operation, Month3
|
Binocular reading speed assessment
Time Frame: Pre-operation, Month3
|
Reading speed assessed by the MNRead acuity chart
|
Pre-operation, Month3
|
Binocular contrast sensitivity
Time Frame: Pre-operation, Month3
|
Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
|
Pre-operation, Month3
|
Distance visual acuity
Time Frame: Pre-operation, Day1, Week1, Month1, Month3
|
Monocular and binocular uncorrected and corrected distance visual acuity
|
Pre-operation, Day1, Week1, Month1, Month3
|
Intermediate (66 cm) visual acuity
Time Frame: Month3
|
Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity
|
Month3
|
Near (40 cm) visual acuity
Time Frame: Month3
|
Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity
|
Month3
|
Binocular defocus curve
Time Frame: Month3
|
Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2)
|
Month3
|
Photic phenomena
Time Frame: Pre-operation, Month3
|
Evaluation of photic phenomena by the 30-item quality of vision questionnaire
|
Pre-operation, Month3
|
Quality of life assessment
Time Frame: Pre-operation, Month3
|
National Eye Institute 25-item Visual Function Questionnaire Rasch score
|
Pre-operation, Month3
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Leung, MD, MB ChB, The University of Hong Kong
Publications and helpful links
General Publications
- Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.
- Zhang F, Sugar A, Jacobsen G, Collins M. Visual function and spectacle independence after cataract surgery: bilateral diffractive multifocal intraocular lenses versus monovision pseudophakia. J Cataract Refract Surg. 2011 May;37(5):853-8. doi: 10.1016/j.jcrs.2010.12.041.
- Mahrous A, Ciralsky JB, Lai EC. Revisiting monovision for presbyopia. Curr Opin Ophthalmol. 2018 Jul;29(4):313-317. doi: 10.1097/ICU.0000000000000487.
- Chen M, Atebara NH, Chen TT. A comparison of a monofocal Acrysoft IOL using the "blended monovision" formula with the multifocal array IOL for glasses independence after cataract surgery. Ann Ophthalmol (Skokie). 2007 Fall;39(3):237-40. doi: 10.1007/s12009-007-0035-4.
- Goldberg DG, Goldberg MH, Shah R, Meagher JN, Ailani H. Pseudophakic mini-monovision: high patient satisfaction, reduced spectacle dependence, and low cost. BMC Ophthalmol. 2018 Nov 9;18(1):293. doi: 10.1186/s12886-018-0963-3.
- Smith CE, Allison RS, Wilkinson F, Wilcox LM. Monovision: Consequences for depth perception from large disparities. Exp Eye Res. 2019 Jun;183:62-67. doi: 10.1016/j.exer.2018.09.005. Epub 2018 Sep 17.
- Lam AKN, To E, Weinreb RN, Yu M, Mak H, Lai G, Chiu V, Wu K, Zhang X, Cheng TPH, Guo PY, Leung CKS. Use of Virtual Reality Simulation to Identify Vision-Related Disability in Patients With Glaucoma. JAMA Ophthalmol. 2020 May 1;138(5):490-498. doi: 10.1001/jamaophthalmol.2020.0392.
- Dick HB, Ang RE, Corbett D, Hoffmann P, Tetz M, Villarrubia A, Palomino C, Castillo-Gomez A, Tsai L, Thomas EK, Janakiraman P. Comparison of 3-month visual outcomes of a new multifocal intraocular lens vs a trifocal intraocular lens. J Cataract Refract Surg. 2022 Nov 1;48(11):1270-1276. doi: 10.1097/j.jcrs.0000000000000971. Epub 2022 May 12.
- Ferreira TB, Ribeiro FJ, Silva D, Matos AC, Gaspar S, Almeida S. Comparison of refractive and visual outcomes of 3 presbyopia-correcting intraocular lenses. J Cataract Refract Surg. 2022 Mar 1;48(3):280-287. doi: 10.1097/j.jcrs.0000000000000743.
- Ramulu PY, Swenor BK, Jefferys JL, Rubin GS. Description and validation of a test to evaluate sustained silent reading. Invest Ophthalmol Vis Sci. 2013 Jan 23;54(1):673-80. doi: 10.1167/iovs.12-10617.
- Mangione CM, Lee PP, Pitts J, Gutierrez P, Berry S, Hays RD. Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. Arch Ophthalmol. 1998 Nov;116(11):1496-504. doi: 10.1001/archopht.116.11.1496.
- Petrillo J, Cano SJ, McLeod LD, Coon CD. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples. Value Health. 2015 Jan;18(1):25-34. doi: 10.1016/j.jval.2014.10.005. Erratum In: Value Health. 2015 Jun;18(4):547.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H022_Protocol_VR Cataract
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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