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

NCT ID: NCT04900662

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-05
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Cataract

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sherif R El-Defrawy

Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kensington Eye Institute

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Mano Chandrakumar

Role: primary

mchandrakumar@KensingtonHealth.org

6472050493

References

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Other Identifiers

KEI20190718

Identifier Type: -

Identifier Source: org_study_id