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CataractNCT06015334

Assessment of Visual Performance With Virtual Reality After Cataract Surgery

A study testing cataract surgery with implantation of intraocular lens in people with Cataract, run by The University of Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Cataract
What is being tested?
cataract surgery with implantation of intraocular lens
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
No sites listed yet
Study dates
1 Oct 2023to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

ChristopherAnita Yau contact

39102673

anitayky@hku.hk

About this study

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.

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.

Read the 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.

Conditions
Cataract
Being tested
cataract surgery with implantation of intraocular lens
Keywords
cataract, virtual reality, multifocal intraocular lens, trifocal intraocular lens, monovision
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cataract surgery with implantation of intraocular lensProcedure or surgery

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

Study groups in NCT06015334
Study groupRoleWhat they receive
Bilateral implantation of trifocal intraocular lensActive comparatorPatients will receive bilateral implantation of TECNIS Synergy intraocular lens
Receives: Procedure: cataract surgery with implantation of intraocular lens
Bilateral monofocal intraocular lens implantation with monovisionActive comparatorPatients will receive bilateral implantation of TECNIS monofocal intraocular lens
Receives: Procedure: cataract surgery with implantation of intraocular lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Virtual reality (VR) performance score

    VR performance score measured from all VR simulations

    Measured: Pre-operation, Month3

Secondary outcomes (9)

  1. Task-specific VR performance score

    VR performance score measured from an individual VR simulation

    Measured: Pre-operation, Month3

  2. Binocular reading speed assessment

    Reading speed assessed by the MNRead acuity chart

    Measured: Pre-operation, Month3

  3. Binocular contrast sensitivity

    Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart

    Measured: Pre-operation, Month3

  4. Distance visual acuity

    Monocular and binocular uncorrected and corrected distance visual acuity

    Measured: Pre-operation, Day1, Week1, Month1, Month3

  5. Intermediate (66 cm) visual acuity

    Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity

    Measured: Month3

  6. Near (40 cm) visual acuity

    Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity

    Measured: Month3

  7. Binocular defocus curve

    Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2)

    Measured: Month3

  8. Photic phenomena

    Evaluation of photic phenomena by the 30-item quality of vision questionnaire

    Measured: Pre-operation, Month3

  9. Quality of life assessment

    National Eye Institute 25-item Visual Function Questionnaire Rasch score

    Measured: Pre-operation, Month3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2023
  2. Study start1 Oct 2023 (estimated)
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
Masking
Single blind
Who is masked
Participant
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015334
Sponsor's protocol ID
H022_Protocol_VR Cataract
Status last verified
Aug 2023
First submitted
23 Aug 2023
Last updated
29 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 21511153

  • Mahrous A, Ciralsky JB, Lai EC. Revisiting monovision for presbyopia. Curr Opin Ophthalmol. 2018 Jul;29(4):313-317. doi: 10.1097/ICU.0000000000000487.

    PubMed 29708928

  • 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.

    PubMed 18025632

  • 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.

    PubMed 30413145

  • 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.

    PubMed 30237103

  • 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.

    PubMed 32191274

  • 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.

    PubMed 35545816

  • 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.

    PubMed 34321410

  • 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.

    PubMed 23258146

  • 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.

    PubMed 11448327

  • 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.

    PubMed 9823352

  • 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.

    PubMed 25595231

Questions about this trial

What is this clinical trial studying?

A study testing cataract surgery with implantation of intraocular lens in people with Cataract, run by The University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ChristopherAnita Yau (39102673, anitayky@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Virtual reality (VR) performance score (time frame: Pre-operation, Month3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06015334, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.

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