Patient Satisfaction and Visual Function Following Implantation of Trifocals or Extended Range of Vision Intraocular Lenses

January 25, 2022 updated by: Dr. Sherif R El-Defrawy, Queen's University

Patient Satisfaction and Visual Function Following Implantation of Trifocals or Extended

Cataract surgery is a fast evolving refractive procedure, which aims to restore vision. The majority of intraocular lens (IOL) implants following cataract surgery are monofocal IOLs, which have been designed to improve distance vision by replacing the lens diopter power with a single focal point. Monofocal IOLs have been associated with very few complications related to the material or the technology. However, after the surgery patients are spectacle dependent for near and intermediate tasks. This, in turn, has decreased the patient's post-operative satisfaction and quality of life. Multifocal intraocular lenses (IOLs) were introduced into the market in the 1980s. This type of IOLs provides clear distance and near vision, which affects the quality of life and visual expectations of the patients who receive them. Studies have indicated higher levels of patient's satisfaction with regards to distance and near vision after the implantation of multifocal lenses. With Multifocal IOLs; however, patients are still spectacle dependent for intermediate tasks such as computer work. The recent development of trifocal IOLs has been found to provide optimal near, intermediate, and distance visual performances; decrease spectacle dependence; and increase patient satisfaction.AcrySof®IQ PanOptix™ (PanOptix) was introduced into the market in 2015 with a design that allows the IOL to provide optimal near, intermediate, and distance visual performances; decrease spectacle dependence; and increase patient satisfaction. Despite the benefits of corrected visual acuity at multiple distances, multifocal and/or trifocal IOLs are associated with certain disadvantages, including contrast sensitivity loss, dysphotopsia, halos and glare, which account for over a third of the justifications used for IOL model replacement. Dysphotopsia is the result of light reflecting off the intraocular lens (IOL) onto the retina which causes a variety of visual symptoms that are expressed in a positive or a negative form. Positive dysphotopsia refers to bright artifacts that are noticed in only certain lighting conditions, such as glare and halos. Negative dysphotopsia refers to the formation of a barrier, which prevents light from reaching the retina. The result of the negative form of dysphotopsia is the formation of shadows that are often in the temporal visual field. In 2014, the extended range of vision TECNIS Symfony®IOL (Symfony), with new optical technology using a proprietary achromatic diffractive echelette design, received a CE Mark. However, it was not until 2016 that this IOL became the first extended depth of focus (EDF) IOL to gain approval by the U.S. Food and Drug Administration. This new optical technology corrects the corneal chromatic aberration for enhanced contrast sensitivity, generating a continuous vision for distance through intermediate into near with low incidence of halos and glare. Despite the benefits of EDF IOLs, Monaco et al. conducted a study in Italy and indicated that both PanOptix and Symfony IOLs seemed to be good options for patients with intermediate-vision requirements, whereas the PanOptix IOL may be better for patients with near-vision requirements. A few studies in the literature have evaluated the performance of the PanOptix and Symfony IOLs in Europe. Our current study would add great value to the literature since to the best of our knowledge; this is the first study to address the same IOLs in North America. Cataract surgery expectations are continuously rising, and in an effort to maximize patient satisfaction post-operatively, the appropriateness of a patient for a particular IOL implantation should be evaluated carefully during the pre-operative assessment. Therefore, further research is warranted to evaluate patient satisfaction with both PanOptix and Symfony IOLs. The purpose of this study is to compare the visual outcomes and the subjective satisfaction results between patients implanted with PanOptix and Symfony IOLs.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

480

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
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Recruiting
        • Kensington Eye Institute
        • Contact:
        • Principal Investigator:
          • Sherif El-Defrawy, MD/PhD.
        • Sub-Investigator:
          • Matt Schlenker, MD/MSc.
        • Sub-Investigator:
          • Marko Popovic, MD

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

Sampling Method

Probability Sample

Study Population

Study population is patients receiving cataract surgery at KEI. Sampling is consecutive. No limitation based on gender or sex.

Description

Inclusion Criteria:

- any patient receiving cataract surgery at KEI who is able and willing to participate over 18 years old.

Exclusion Criteria:

- less than 18, not receiving cataract surgery at KEI, not able or willing to participate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient burden from preoperative fasting
Time Frame: 2019-2021
A questionnaire will be used to assess.
2019-2021
incidence of aspiration or cancellation of surgery because of preoperative fasting violation
Time Frame: 2019-2021
A questionnaire will be used to assess.
2019-2021

Collaborators and Investigators

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

Sponsor

Queen's University

Collaborators

University of Toronto

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)

July 5, 2019

Primary Completion (Actual)

August 31, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEI20190718

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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