Assessment of Visual Performance With Virtual Reality After Cataract Surgery

NCT06015334 | Unknown DMC

• 1 other identifier: H022_Protocol_VR Cataract
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

cataract; virtual reality; multifocal intraocular lens; trifocal intraocular lens; monovision

Outcome Measures

Primary Outcomes (1)

• Overall Virtual reality (VR) performance score

  VR performance score measured from all VR simulations

  Pre-operation, Month3

Secondary Outcomes (9)

• Task-specific VR performance score

  Pre-operation, Month3

• Binocular reading speed assessment

  Pre-operation, Month3

• Binocular contrast sensitivity

  Pre-operation, Month3

• Distance visual acuity

  Pre-operation, Day1, Week1, Month1, Month3

• Intermediate (66 cm) visual acuity

  Month3

Study Arms (2)

Bilateral implantation of trifocal intraocular lens

ACTIVE COMPARATOR

Patients will receive bilateral implantation of TECNIS Synergy intraocular lens

Procedure: cataract surgery with implantation of intraocular lens

Bilateral monofocal intraocular lens implantation with monovision

ACTIVE COMPARATOR

Patients will receive bilateral implantation of TECNIS monofocal intraocular lens

Procedure: cataract surgery with implantation of intraocular lens

Interventions

cataract surgery with implantation of intraocular lens PROCEDURE

Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.

Bilateral implantation of trifocal intraocular lens; Bilateral monofocal intraocular lens implantation with monovision

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral cataract
• Regular corneal astigmatism
• Corneal endothelium cell count \>2000 cells/mm2
• Clear intraocular media other than cataract

You may not qualify if:

• Concomitant ocular diseases
• Irregular corneal aberration
• Capsular instability
• Systemic disease that may affect vision
• History of other intraocular surgery

Sponsors & Collaborators

• The University of Hong Kong: lead
• Janssen, LP: collaborator

Related Publications (12)

• 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: 21511153 BACKGROUND

• 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: 29708928 BACKGROUND

• 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: 18025632 BACKGROUND

• 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: 30413145 BACKGROUND

• 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: 30237103 BACKGROUND

• 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: 32191274 BACKGROUND

• 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: 35545816 BACKGROUND

• 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: 34321410 BACKGROUND

• 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: 23258146 BACKGROUND

• 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: 11448327 BACKGROUND

• 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: 9823352 BACKGROUND

• 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.

  PMID: 25595231 BACKGROUND

Related Links

• Probabilistic Models for Some Intelligence and Attainment Tests

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction; Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Christopher Leung, MD, MB ChB

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChristopherAnita Yau

CONTACT

39102673; anitayky@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will remain unaware of their specific study arm assignments until the completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share