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Assessment of Visual Performance With Virtual Reality After Cataract Surgery

Primary Purpose

Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery with implantation of intraocular lens
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, virtual reality, multifocal intraocular lens, trifocal intraocular lens, monovision

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Bilateral implantation of trifocal intraocular lens

    Bilateral monofocal intraocular lens implantation with monovision

    Arm Description

    Patients will receive bilateral implantation of TECNIS Synergy intraocular lens

    Patients will receive bilateral implantation of TECNIS monofocal intraocular lens

    Outcomes

    Primary Outcome Measures

    Overall Virtual reality (VR) performance score
    VR performance score measured from all VR simulations

    Secondary Outcome Measures

    Task-specific VR performance score
    VR performance score measured from an individual VR simulation
    Binocular reading speed assessment
    Reading speed assessed by the MNRead acuity chart
    Binocular contrast sensitivity
    Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
    Distance visual acuity
    Monocular and binocular uncorrected and corrected distance visual acuity
    Intermediate (66 cm) visual acuity
    Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity
    Near (40 cm) visual acuity
    Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity
    Binocular defocus curve
    Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2)
    Photic phenomena
    Evaluation of photic phenomena by the 30-item quality of vision questionnaire
    Quality of life assessment
    National Eye Institute 25-item Visual Function Questionnaire Rasch score

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    August 23, 2023
    Sponsor
    The University of Hong Kong
    Collaborators
    Janssen, LP
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06015334
    Brief Title
    Assessment of Visual Performance With Virtual Reality After Cataract Surgery
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    September 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong
    Collaborators
    Janssen, LP

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    cataract, virtual reality, multifocal intraocular lens, trifocal intraocular lens, monovision

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
    Masking
    Participant
    Masking Description
    Patients will remain unaware of their specific study arm assignments until the completion of the study.
    Allocation
    Randomized
    Enrollment
    114 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bilateral implantation of trifocal intraocular lens
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive bilateral implantation of TECNIS Synergy intraocular lens
    Arm Title
    Bilateral monofocal intraocular lens implantation with monovision
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive bilateral implantation of TECNIS monofocal intraocular lens
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery with implantation of intraocular lens
    Intervention Description
    Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
    Primary Outcome Measure Information:
    Title
    Overall Virtual reality (VR) performance score
    Description
    VR performance score measured from all VR simulations
    Time Frame
    Pre-operation, Month3
    Secondary Outcome Measure Information:
    Title
    Task-specific VR performance score
    Description
    VR performance score measured from an individual VR simulation
    Time Frame
    Pre-operation, Month3
    Title
    Binocular reading speed assessment
    Description
    Reading speed assessed by the MNRead acuity chart
    Time Frame
    Pre-operation, Month3
    Title
    Binocular contrast sensitivity
    Description
    Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
    Time Frame
    Pre-operation, Month3
    Title
    Distance visual acuity
    Description
    Monocular and binocular uncorrected and corrected distance visual acuity
    Time Frame
    Pre-operation, Day1, Week1, Month1, Month3
    Title
    Intermediate (66 cm) visual acuity
    Description
    Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity
    Time Frame
    Month3
    Title
    Near (40 cm) visual acuity
    Description
    Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity
    Time Frame
    Month3
    Title
    Binocular defocus curve
    Description
    Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2)
    Time Frame
    Month3
    Title
    Photic phenomena
    Description
    Evaluation of photic phenomena by the 30-item quality of vision questionnaire
    Time Frame
    Pre-operation, Month3
    Title
    Quality of life assessment
    Description
    National Eye Institute 25-item Visual Function Questionnaire Rasch score
    Time Frame
    Pre-operation, Month3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ChristopherAnita Yau
    Phone
    39102673
    Email
    anitayky@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Leung, MD, MB ChB
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.
    Citations:
    PubMed Identifier
    21511153
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29708928
    Citation
    Mahrous A, Ciralsky JB, Lai EC. Revisiting monovision for presbyopia. Curr Opin Ophthalmol. 2018 Jul;29(4):313-317. doi: 10.1097/ICU.0000000000000487.
    Results Reference
    background
    PubMed Identifier
    18025632
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30413145
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30237103
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32191274
    Citation
    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.
    Results Reference
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    PubMed Identifier
    35545816
    Citation
    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.
    Results Reference
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    PubMed Identifier
    34321410
    Citation
    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.
    Results Reference
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    PubMed Identifier
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    Citation
    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.
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    PubMed Identifier
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    Citation
    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.
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    Citation
    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.
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    Citation
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    Links:
    URL
    https://www.semanticscholar.org/paper/Probabilistic-Models-for-Some-Intelligence-and-Rasch/d3203958e1b9c007d06340aad11d41f088875f3e#citing-papers
    Description
    Probabilistic Models for Some Intelligence and Attainment Tests

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