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

• ClinicalTrials.gov Identifier: NCT04652037
• Recruitment Status: Recruiting
• First Posted: December 3, 2020
• Last Update Posted: November 3, 2021
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Information provided by (Responsible Party): Centre hospitalier de l'Université de Montréal (CHUM)

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Cataract; Presbyopia; Corneal Astigmatism	Device: Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visual Outcomes and Rotational Stability of the Acrysof IQ Vivity Toric Extended Vision Intraocular Lens
• Actual Study Start Date: March 17, 2021
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation	Device: Acrysof IQ Vivity Toric Extended Vision 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); Other Name: DFT315, DFT415, or DFT515 Intraocular Lens Implantation

Outcome Measures

Primary Outcome Measures :

1. Binocular uncorrected visual acuities for distance (6 meters), intermediate (66 centimeters), and near (40 centimeters) [ Time Frame: 3 months ]
   Evaluation of visual acuity, measured using the Snellen chart.

Secondary Outcome Measures :

1. Mean absolute intraocular lens rotation (subjective) [ Time Frame: 1 day, 1 week, 3 months ]
   Mean absolute calculation of intraocular lens rotation compared to axis of placement using slit-lamp measurements (in degrees)
2. Percentage of toric intraocular lenses within 5 degrees of axis of placement [ Time Frame: 3 months ]
   Percentage calculation using the number of intraocular lens that have rotated within less than 5 degrees of axis of placement using slit-lamp measurements
3. Postoperative residual astigmatism [ Time Frame: 3 months ]
   Measurement of astigmatism using manifest refraction measurements (in diopters)
4. Monocular best corrected distance visual acuities (at 6 meters), and distance corrected intermediate (66 centimeters) and near (40 centimeters) visual acuities [ Time Frame: 3 months ]
   Evaluation of visual acuity, measured using the Snellen chart, while correcting refractive error for distance vision only.
5. Mean refractive spherical equivalent [ Time Frame: 3 months ]
   Calculations of mean refractive spherical equivalent based on manifest refraction measurements (in diopters)
6. Refractive accuracy [ Time Frame: 3 months ]
   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)
7. Patient reported visual disturbances [ Time Frame: 3 months ]
   Evaluation of patient reported visual disturbances using a validated questionnaire for visual disturbances (QUVID)

Other Outcome Measures:

1. Mean absolute intraocular lens rotation (objective) [ Time Frame: 1 day, 1 week, 3 months ]
   Mean absolute calculation of intraocular lens rotation compared to axis of placement using measures from the OPD-Scan (in degrees)
2. Mean absolute prediction error [ Time Frame: 3 months ]
   Mean absolute calculation of prediction error based on manifest refraction measurements (in diopters)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Contacts and Locations

Contacts

Contact: Marie-Catherine Tessier, MSc; 1-514-890-8000 ext 11550; marie-catherine.tessier.chum@ssss.gouv.qc.ca

Contact: Michael Trong Duc Nguyen, MD; 1-514-890-8000 ext 11550; michael.nguyen.1@umontreal.ca

Locations

Canada, Quebec

Centre hospitalier de l'Université de Montréal (CHUM); Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contact: Marie-Catherine Tessier, MSc 1-514-890-8000 ext 11550 marie-catherine.tessier.chum@ssss.gouv.qc.ca

Principal Investigator: Georges Durr, MD, FRCSC

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

• Principal Investigator: Georges Durr, MD, FRCSC; Centre hospitalier de l'Université de Montréal (CHUM)

More Information

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. Review.

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. Review.

Talley-Rostov A. Patient-centered care and refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):5-9. Review.

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.

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. Review.

Keates RH, Pearce JL, Schneider RT. Clinical results of the multifocal lens. J Cataract Refract Surg. 1987 Sep;13(5):557-60.

Alio JL, Plaza-Puche AB, Férnandez-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. Review.

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:CD003169. doi: 10.1002/14651858.CD003169.pub4. Review.

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.

Domínguez-Vicent A, Esteve-Taboada JJ, Del Águila-Carrasco AJ, Monsálvez-Romin D, Montés-Micó 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.

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.

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.

Ferrer-Blasco T, Montés-Micó R, Peixoto-de-Matos SC, González-Méijome JM, Cerviño 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.

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.

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. Review.

Miyake T, Kamiya K, Amano R, Iida Y, Tsunehiro S, Shimizu K. Long-term clinical outcomes of toric intraocular lens implantation in cataract cases with preexisting astigmatism. J Cataract Refract Surg. 2014 Oct;40(10):1654-60. doi: 10.1016/j.jcrs.2014.01.044. Epub 2014 Aug 20.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT04652037
• Other Study ID Numbers: 20.263
• First Posted: December 3, 2020
• Last Update Posted: November 3, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):

Extended Vision Intraocular Lens; Toric Intraocular Lens; Visual Outcomes; Rotational Stability; Postoperative Visual Disturbances; Patient Satisfaction; Cataract Surgery

Additional relevant MeSH terms:

Cataract; Astigmatism; Presbyopia; Lens Diseases; Eye Diseases; Refractive Errors