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

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Recruiting
CT.gov ID
NCT04652037
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
13.5
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase
  • Device: Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation
N/A

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
Anticipated 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 :
Mar 17, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

ArmIntervention/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 Names:
  • 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) [3 months]

      Evaluation of visual acuity, measured using the Snellen chart.

    Secondary Outcome Measures

    1. Mean absolute intraocular lens rotation (subjective) [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 [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 [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 [3 months]

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

    5. Mean refractive spherical equivalent [3 months]

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

    6. Refractive accuracy [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 [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) [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 [3 months]

      Mean absolute calculation of prediction error based on manifest refraction measurements (in diopters)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    SiteCityStateCountryPostal Code
    1Centre hospitalier de l'Université de Montréal (CHUM)MontrealQuebecCanadaH2X 3E4

    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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Centre hospitalier de l'Université de Montréal (CHUM)
    ClinicalTrials.gov Identifier:
    NCT04652037
    Other Study ID Numbers:
    • 20.263
    First Posted:
    Dec 3, 2020
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    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)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021