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

NCT04652037 | Completed

• 1 other identifier: 20.263
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia; Corneal Astigmatism

Keywords

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

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (7)

• Mean absolute intraocular lens rotation (subjective)

  1 day, 1 week, 3 months

• Percentage of toric intraocular lenses within 5 degrees of axis of placement

  3 months

• Postoperative residual astigmatism

  3 months

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

  3 months

• Mean refractive spherical equivalent

  3 months

Other Outcomes (2)

• Mean absolute intraocular lens rotation (objective)

  1 day, 1 week, 3 months

• Mean absolute prediction error

  3 months

Study Arms (1)

Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation

EXPERIMENTAL

Device: Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation

Interventions

Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation DEVICE

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)

Also known as: DFT315, DFT415, or DFT515 Intraocular Lens Implantation

Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (16)

• 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.

  PMID: 22133988 BACKGROUND

• 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.

  PMID: 29032195 BACKGROUND

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

  PMID: 18090889 BACKGROUND

• 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.

  PMID: 16338569 BACKGROUND

• 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.

  PMID: 30993062 BACKGROUND

• 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.

  PMID: 3312575 BACKGROUND

• 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.

  PMID: 28366683 BACKGROUND

• 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.

  PMID: 27943250 BACKGROUND

• 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.

  PMID: 25250421 BACKGROUND

• 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.

  PMID: 26948789 BACKGROUND

• 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.

  PMID: 29634837 BACKGROUND

• 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.

  PMID: 30089179 BACKGROUND

• 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.

  PMID: 19101427 BACKGROUND

• 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.

  PMID: 7996408 BACKGROUND

• 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.

  PMID: 29208810 BACKGROUND

• 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.

  PMID: 25149554 BACKGROUND

MeSH Terms

Conditions

Cataract; Presbyopia; Astigmatism; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Georges Durr, MD, FRCSC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 3, 2020
• Study Start: March 17, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 5, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)