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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D019654', 'term': 'Lens Implantation, Intraocular'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will remain unaware of their specific study arm assignments until the completion of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Virtual reality (VR) performance score', 'timeFrame': 'Pre-operation, Month3', 'description': 'VR performance score measured from all VR simulations'}], 'secondaryOutcomes': [{'measure': 'Task-specific VR performance score', 'timeFrame': 'Pre-operation, Month3', 'description': 'VR performance score measured from an individual VR simulation'}, {'measure': 'Binocular reading speed assessment', 'timeFrame': 'Pre-operation, Month3', 'description': 'Reading speed assessed by the MNRead acuity chart'}, {'measure': 'Binocular contrast sensitivity', 'timeFrame': 'Pre-operation, Month3', 'description': 'Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart'}, {'measure': 'Distance visual acuity', 'timeFrame': 'Pre-operation, Day1, Week1, Month1, Month3', 'description': 'Monocular and binocular uncorrected and corrected distance visual acuity'}, {'measure': 'Intermediate (66 cm) visual acuity', 'timeFrame': 'Month3', 'description': 'Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity'}, {'measure': 'Near (40 cm) visual acuity', 'timeFrame': 'Month3', 'description': 'Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity'}, {'measure': 'Binocular defocus curve', 'timeFrame': 'Month3', 'description': 'Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela \\[cd\\]/m2)'}, {'measure': 'Photic phenomena', 'timeFrame': 'Pre-operation, Month3', 'description': 'Evaluation of photic phenomena by the 30-item quality of vision questionnaire'}, {'measure': 'Quality of life assessment', 'timeFrame': 'Pre-operation, Month3', 'description': 'National Eye Institute 25-item Visual Function Questionnaire Rasch score'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cataract', 'virtual reality', 'multifocal intraocular lens', 'trifocal intraocular lens', 'monovision'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '21511153', 'type': 'BACKGROUND', '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.'}, {'pmid': '29708928', 'type': 'BACKGROUND', '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.'}, {'pmid': '18025632', 'type': 'BACKGROUND', '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.'}, {'pmid': '30413145', 'type': 'BACKGROUND', '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.'}, {'pmid': '30237103', 'type': 'BACKGROUND', '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.'}, {'pmid': '32191274', 'type': 'BACKGROUND', '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.'}, {'pmid': '35545816', 'type': 'BACKGROUND', '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.'}, {'pmid': '34321410', 'type': 'BACKGROUND', '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.'}, {'pmid': '23258146', 'type': 'BACKGROUND', '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.'}, {'pmid': '11448327', 'type': 'BACKGROUND', '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.'}, {'pmid': '9823352', 'type': 'BACKGROUND', '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.'}, {'pmid': '25595231', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.semanticscholar.org/paper/Probabilistic-Models-for-Some-Intelligence-and-Rasch/d3203958e1b9c007d06340aad11d41f088875f3e#citing-papers', 'label': 'Probabilistic Models for Some Intelligence and Attainment Tests'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral cataract\n* Regular corneal astigmatism\n* Corneal endothelium cell count \\>2000 cells/mm2\n* Clear intraocular media other than cataract\n\nExclusion Criteria:\n\n* Concomitant ocular diseases\n* Irregular corneal aberration\n* Capsular instability\n* Systemic disease that may affect vision\n* History of other intraocular surgery'}, 'identificationModule': {'nctId': 'NCT06015334', 'briefTitle': 'Assessment of Visual Performance With Virtual Reality After Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'H022_Protocol_VR Cataract'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral implantation of trifocal intraocular lens', 'description': 'Patients will receive bilateral implantation of TECNIS Synergy intraocular lens', 'interventionNames': ['Procedure: cataract surgery with implantation of intraocular lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral monofocal intraocular lens implantation with monovision', 'description': 'Patients will receive bilateral implantation of TECNIS monofocal intraocular lens', 'interventionNames': ['Procedure: cataract surgery with implantation of intraocular lens']}], 'interventions': [{'name': 'cataract surgery with implantation of intraocular lens', 'type': 'PROCEDURE', 'description': 'Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.', 'armGroupLabels': ['Bilateral implantation of trifocal intraocular lens', 'Bilateral monofocal intraocular lens implantation with monovision']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ChristopherAnita Yau', 'role': 'CONTACT', 'email': 'anitayky@hku.hk', 'phone': '39102673'}], 'overallOfficials': [{'name': 'Christopher Leung, MD, MB ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Professor Christopher K.S. Leung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}