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

December 12, 2022 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • DFT315, DFT415, or DFT515 Intraocular Lens Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day, 1 week, 3 months
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 months
Postoperative residual astigmatism
Time Frame: 3 months
Measurement of astigmatism using manifest refraction measurements (in diopters)
3 months
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.
3 months
Mean refractive spherical equivalent
Time Frame: 3 months
Calculations of mean refractive spherical equivalent based on manifest refraction measurements (in diopters)
3 months
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)
3 months
Patient reported visual disturbances
Time Frame: 3 months
Evaluation of patient reported visual disturbances using a validated questionnaire for visual disturbances (QUVID)
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day, 1 week, 3 months
Mean absolute prediction error
Time Frame: 3 months
Mean absolute calculation of prediction error based on manifest refraction measurements (in diopters)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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