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CataractNCT04652037

Visual Results of the Acrysof IQ Vivity Toric Extended Vision Intraocular Lens

A study testing Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation in people with Cataract and Presbyopia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main goal of this study is to evaluate real-world visual outcomes, rotational stability, and patient reported visual disturbances with a non-diffractive extended vision presbyopia and astigmatism correcting intraocular lens in patients with significant corneal astigmatism undergoing bilateral cataract surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract, Presbyopia, Corneal Astigmatism
What is being tested?
Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
17 Mar 2021to 5 Dec 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing uncomplicated cataract surgery with intraocular lens implantation
  • Patients motivated by a greater degree of spectacle independence
  • Patients possessing with-the-rule astigmatism of ≥ 0.75 diopters (D) or against-the-rule astigmatism of ≥ 0.50 D
  • Patients for whom the Barrett Toric Calculator suggests T3-T5 cylinder power AND 15D-25D spherical power in both eyes
  • Ability to provide informed consent;
  • Ability to be followed for the entire duration of the study.

Who cannot join

  • Ocular comorbidity that might hamper postoperative visual acuity
  • Previous refractive surgery
  • Expected post-op visual acuity worse than 20/25 (on Snellen chart)
  • Refractive lens exchange
  • Irregular corneal astigmatism and keratoconus
  • Angle Kappa/chord mu ≥ 0.7
Show all 11Show fewer
  • Higher order corneal aberrations > 0.6 root mean square (RMS) units (to exclude irregular corneas)
  • Difficulties comprehending written or spoken French or English language
  • Patients with physical or intellectual disability (e.g. Down syndrome, Parkinson's disease; unable to fixate)
  • Ocular surface disease
  • Axial length > 26mm

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

Other trials in Canada

About this study

Official title: Visual Outcomes and Rotational Stability of the Acrysof IQ Vivity Toric Extended Vision Intraocular Lens

The main goal of this study is to evaluate real-world visual outcomes, rotational stability, and patient reported visual disturbances with a non-diffractive extended vision presbyopia and astigmatism correcting intraocular lens in patients with significant corneal astigmatism undergoing bilateral cataract surgery. This is important to ensure optimal results for patients who wish to have intraocular lenses that correct presbyopia and astigmatism, thus giving them a greater independence from spectacles and a better quality of life.

Read the detailed description

It is estimated that cataracts are the cause of 33% of visual impairment and 51% of total blindness worldwide. Indeed, they are the most important cause of total blindness and preventable blindness in the world. To reduce the burden of this disease, many advances have been made in the field of cataract surgery and have resulted in better visual outcomes. With the development of different types of intraocular lenses over the years, it is now possible to not only treat cataracts, but also tackle presbyopia and astigmatism to increase patients' independence from spectacles and thus improving quality of life. Indeed, the desire for independence from corrective lenses is an important motivation for many patients, which explains the increasingly common use of intraocular lenses correcting for presbyopia.

For most uncomplicated cataract surgeries today in Quebec, Canada, monofocal lens are implanted and their cost is covered by the government. Generally, this lens allows patients to be emmetropic, which translates to good distance vision. However, these patients will need reading glasses for intermediate and near vision. A good proportion of patients are unsatisfied with being dependent on corrective lenses, especially if they did not have any before surgery. There is a correction technique for presbyopia called "monovision", which involves making the patient's dominant eye emmetropic and making the other eye more myopic. This way, the patient can use the myopic eye for intermediate and near vision. Intermediate vision is useful for computer work, for example, while near vision is useful for reading. "Monovision" requires good tolerance of anisometropia by the patient and may interfere with stereoacuity, which may limit its use.

Multifocal intraocular lenses were first implanted in 1986, but took several years to become more commonly adopted. The terms "bifocal" or "trifocal" refer to the number of distinct foci in the lens, allowing the patient to see at different distances. The simultaneous perception of these multiple focal points can be initially disturbing for the patient and may require several months of postoperative neuroadaptation. There are two types of multifocal lenses: refractive and diffractive lenses. Refractive lenses have concentric rings centrifugally increasing in dioptric power on their anterior surface. Diffractive lenses, on the other hand, have diffractive rings on their posterior portion. Meta-analyses have shown that multifocal lenses cause visual disturbances, such as halos and glare, that are more bothersome and frequent than in "monovision". However, multifocal lenses show better rates of independence from spectacles than "monovision". Refractive multifocal lenses, compared to diffractive lenses, tend to produce more glare, halos and higher-order aberrations. However, refractive lenses tend to produce better uncorrected distance visual acuity, while diffractive lenses tend to perform better for near vision.

Finally, extended depth of focus (EDOF) lenses are a newer technology that will be discussed in this study. They have an extended continuous focal point as opposed to the fixed focal points of multifocal lenses, which allows for less superimposition of near and far images compared to multifocal lenses. Theoretical interferometry studies also suggest that EDOF lenses produce better images in between intermediate and near vision. A few comparative studies have shown that EDOF lenses show equal or poorer near visual acuity than diffractive lenses, but have equal or better results for intermediate visual acuity. There are also other newer types of intraocular lenses that, due to their novelty, lack enough data at this time. These include accommodative lenses, postoperative non-invasively adjustable lenses and electronic lenses.

Astigmatism is a refractive error caused by an irregularity in the cornea and/or the crystalline lens that prevents the eye from focusing light evenly on the retina. It causes blurred vision at all distances. It is estimated that almost two-thirds of patients undergoing cataract surgery have preoperative corneal astigmatism between 0.25 and 1.25 diopters. 22% of these patients have astigmatism of 1.50 diopters or more. Toric intraocular lens implantation, first introduced in 1992, is the procedure of choice to correct significant corneal astigmatism (1.00 diopter or greater). For optimal correction of astigmatism with the toric lens, precise alignment of the actual lens axis with the calculated preoperative lens axis of placement is required. This is influenced by several factors, a major one being the rotational stability of the lens. Maximum rotational stability has been observed with hydrophobic acrylic lenses. A prospective study with AcrySof Toric lenses showed significant postoperative rotation of more than 10 degrees in only 1.68% of eyes. In fact, the Acrysof IQ Vivity Toric Extended Vision Intraocular Lens is made with the same AcrySof material, which has shown excellent postoperative rotational stability.

To our knowledge, no study to this day has evaluated the refractive visual outcomes of the Acrysof IQ Vivity Toric Extended Vision Intraocular Lens for the correction of presbyopia and corneal astigmatism. This is believed to be the first study of the Acrysof IQ Vivity Toric Extended Vision Intraocular Lens in Canada. Studying the impact of the Acrysof IQ Vivity Toric Extended Vision Intraocular Lens will provide real-world data on visual acuities after bilateral cataract surgery, intraocular lens rotational stability and subjective assessment of postoperative visual disturbances. This is important to ensure optimal results for patients who wish to have intraocular lenses that correct presbyopia and astigmatism, thus giving them a greater independence from spectacles and a better quality of life.

Being tested
Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation
Keywords
Extended Vision Intraocular Lens, Toric Intraocular Lens, Visual Outcomes, Rotational Stability, Postoperative Visual Disturbances, Patient Satisfaction, Cataract Surgery
Medical subject headings
Cataract, Presbyopia, Astigmatism, Patient Satisfaction

What participants receive

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

  • Acrysof IQ Vivity Toric Extended Vision Intraocular Lens ImplantationDevice

    Also called DFT315, DFT415, or DFT515 Intraocular Lens Implantation

    Implantation during bilateral cataract surgery of a new non-diffractive extended vision presbyopia and astigmatism correcting intraocular lens (Acrysof IQ Vivity Toric Extended Vision Intraocular Lens)

Study groups in NCT04652037
Study groupRoleWhat they receive
Acrysof IQ Vivity Toric Extended Vision Intraocular Lens ImplantationExperimentalNot described
Receives: Device: Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation

What is being measured

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

  1. Binocular uncorrected visual acuities for distance (6 meters), intermediate (66 centimeters), and near (40 centimeters)

    Evaluation of visual acuity, measured using the Snellen chart.

    Measured: 3 months

Secondary outcomes (7)
  1. Mean absolute intraocular lens rotation (subjective)

    Mean absolute calculation of intraocular lens rotation compared to axis of placement using slit-lamp measurements (in degrees)

    Measured: 1 day, 1 week, 3 months

  2. Percentage of toric intraocular lenses within 5 degrees of axis of placement

    Percentage calculation using the number of intraocular lens that have rotated within less than 5 degrees of axis of placement using slit-lamp measurements

    Measured: 3 months

  3. Postoperative residual astigmatism

    Measurement of astigmatism using manifest refraction measurements (in diopters)

    Measured: 3 months

  4. Monocular best corrected distance visual acuities (at 6 meters), and distance corrected intermediate (66 centimeters) and near (40 centimeters) visual acuities

    Evaluation of visual acuity, measured using the Snellen chart, while correcting refractive error for distance vision only.

    Measured: 3 months

  5. Mean refractive spherical equivalent

    Calculations of mean refractive spherical equivalent based on manifest refraction measurements (in diopters)

    Measured: 3 months

  6. Refractive accuracy

    Percentage calculation of the number of eyes with an absolute prediction error of 0.50 diopters or less based on manifest refraction measurements (in diopters)

    Measured: 3 months

  7. Patient reported visual disturbances

    Evaluation of patient reported visual disturbances using a validated questionnaire for visual disturbances (QUVID)

    Measured: 3 months

Timeline

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

  1. First posted3 Dec 2020
  2. Study start17 Mar 2021
  3. Primary completion30 Sep 2022
  4. Study completion5 Dec 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652037
Sponsor's protocol ID
20.263
Status last verified
Dec 2022
First submitted
23 Nov 2020
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012 May;96(5):614-8. doi: 10.1136/bjophthalmol-2011-300539. Epub 2011 Dec 1.

    PubMed 22133988
  • Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, Das A, Jonas JB, Keeffe J, Kempen JH, Leasher J, Limburg H, Naidoo K, Pesudovs K, Silvester A, Stevens GA, Tahhan N, Wong TY, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017 Dec;5(12):e1221-e1234. doi: 10.1016/S2214-109X(17)30393-5. Epub 2017 Oct 11.

    PubMed 29032195
  • Talley-Rostov A. Patient-centered care and refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):5-9. doi: 10.1097/ICU.0b013e3282f2d7a3.

    PubMed 18090889
  • Hawker MJ, Madge SN, Baddeley PA, Perry SR. Refractive expectations of patients having cataract surgery. J Cataract Refract Surg. 2005 Oct;31(10):1970-5. doi: 10.1016/j.jcrs.2005.03.065.

    PubMed 16338569
  • Sieburth R, Chen M. Intraocular lens correction of presbyopia. Taiwan J Ophthalmol. 2019 Jan-Mar;9(1):4-17. doi: 10.4103/tjo.tjo_136_18.

    PubMed 30993062
  • Keates RH, Pearce JL, Schneider RT. Clinical results of the multifocal lens. J Cataract Refract Surg. 1987 Sep;13(5):557-60. doi: 10.1016/s0886-3350(87)80114-1.

    PubMed 3312575
  • Alio JL, Plaza-Puche AB, Fernandez-Buenaga R, Pikkel J, Maldonado M. Multifocal intraocular lenses: An overview. Surv Ophthalmol. 2017 Sep-Oct;62(5):611-634. doi: 10.1016/j.survophthal.2017.03.005. Epub 2017 Mar 31.

    PubMed 28366683
  • de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.

    PubMed 27943250
  • Xu X, Zhu MM, Zou HD. Refractive versus diffractive multifocal intraocular lenses in cataract surgery: a meta-analysis of randomized controlled trials. J Refract Surg. 2014 Sep;30(9):634-44. doi: 10.3928/1081597X-20140814-04.

    PubMed 25250421
  • Dominguez-Vicent A, Esteve-Taboada JJ, Del Aguila-Carrasco AJ, Monsalvez-Romin D, Montes-Mico R. In vitro optical quality comparison of 2 trifocal intraocular lenses and 1 progressive multifocal intraocular lens. J Cataract Refract Surg. 2016 Jan;42(1):138-47. doi: 10.1016/j.jcrs.2015.06.040.

    PubMed 26948789
  • Savini G, Schiano-Lomoriello D, Balducci N, Barboni P. Visual Performance of a New Extended Depth-of-Focus Intraocular Lens Compared to a Distance-Dominant Diffractive Multifocal Intraocular Lens. J Refract Surg. 2018 Apr 1;34(4):228-235. doi: 10.3928/1081597X-20180125-01.

    PubMed 29634837
  • Cochener B, Boutillier G, Lamard M, Auberger-Zagnoli C. A Comparative Evaluation of a New Generation of Diffractive Trifocal and Extended Depth of Focus Intraocular Lenses. J Refract Surg. 2018 Aug 1;34(8):507-514. doi: 10.3928/1081597X-20180530-02.

    PubMed 30089179
  • Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, Gonzalez-Meijome JM, Cervino A. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg. 2009 Jan;35(1):70-5. doi: 10.1016/j.jcrs.2008.09.027.

    PubMed 19101427
  • Shimizu K, Misawa A, Suzuki Y. Toric intraocular lenses: correcting astigmatism while controlling axis shift. J Cataract Refract Surg. 1994 Sep;20(5):523-6. doi: 10.1016/s0886-3350(13)80232-5.

    PubMed 7996408
  • Kaur M, Shaikh F, Falera R, Titiyal JS. Optimizing outcomes with toric intraocular lenses. Indian J Ophthalmol. 2017 Dec;65(12):1301-1313. doi: 10.4103/ijo.IJO_810_17.

    PubMed 29208810

Questions about this trial

What is this clinical trial studying?

A study testing Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation in people with Cataract and Presbyopia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

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 6 inclusion and 11 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: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binocular uncorrected visual acuities for distance (6 meters), intermediate (66 centimeters), and near (40 centimeters) (time frame: 3 months). 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 NCT04652037, which also lists 16 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 13 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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