Assessment of Visual Performance With Virtual Reality After Cataract Surgery

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06015334
• Other study ID #: H022_Protocol_VR Cataract
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: The University of Hong Kong
• Contact: ChristopherAnita Yau
• Phone: 39102673
• Email: anitayky[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Janssen, LP

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Value Health. 2015 Jun;18(4):547. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Virtual reality (VR) performance score	VR performance score measured from all VR simulations	Pre-operation, Month3
Secondary	Task-specific VR performance score	VR performance score measured from an individual VR simulation	Pre-operation, Month3
Secondary	Binocular reading speed assessment	Reading speed assessed by the MNRead acuity chart	Pre-operation, Month3
Secondary	Binocular contrast sensitivity	Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart	Pre-operation, Month3
Secondary	Distance visual acuity	Monocular and binocular uncorrected and corrected distance visual acuity	Pre-operation, Day1, Week1, Month1, Month3
Secondary	Intermediate (66 cm) visual acuity	Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity	Month3
Secondary	Near (40 cm) visual acuity	Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity	Month3
Secondary	Binocular defocus curve	Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2)	Month3
Secondary	Photic phenomena	Evaluation of photic phenomena by the 30-item quality of vision questionnaire	Pre-operation, Month3
Secondary	Quality of life assessment	National Eye Institute 25-item Visual Function Questionnaire Rasch score	Pre-operation, Month3

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