CataractNCT04900662
Patient Satisfaction and Visual Function Following Implantation of Trifocals or Extended Range of Vision Intraocular Lenses
An observational study of Cataract, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- How many people
- 480 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is patients receiving cataract surgery at KEI. Sampling is consecutive. No limitation based on gender or sex.
Who may be able to join
- any patient receiving cataract surgery at KEI who is able and willing to participate over 18 years old.
Who cannot join
- less than 18, not receiving cataract surgery at KEI, not able or willing to participate
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kensington Eye Institute
Toronto, Ontario, M5T 3A9
Mano Chandrakumar, 6472050493, mchandrakumar@KensingtonHealth.org
Sherif El-Defrawy, MD/PhD.
About this study
Official title: 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.
- Conditions
- Cataract
- Keywords
- cataract surgery, quality of life, preoperative fasting
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
patient burden from preoperative fasting
A questionnaire will be used to assess.
Measured: 2019-2021
incidence of aspiration or cancellation of surgery because of preoperative fasting violation
A questionnaire will be used to assess.
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start5 Jul 2019
- Primary completion31 Aug 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Dr. Sherif R El-Defrawy, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900662
- Sponsor's protocol ID
- KEI20190718
- Status last verified
- Jan 2022
- First submitted
- 6 Oct 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
PubMed 22972061de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
PubMed 29138533Santos BWL, Cançado JEP, Ferraz VAdS, Campos M. Evaluation of life quality of patients submitted to cataract surgery with implants of monofocal, bifocal and multifocal lenses. Revista Brasileira de Oftalmologia 2014;73:86-92
Gundersen KG, Potvin R. Comparative visual performance with monofocal and multifocal intraocular lenses. Clin Ophthalmol. 2013;7:1979-85. doi: 10.2147/OPTH.S52922. Epub 2013 Oct 7.
PubMed 24143064Cochener B, Vryghem J, Rozot P, Lesieur G, Chevalier JP, Henry JM, David T, Lesueur L, Gatinel D, Ganem C, Blanckaert J, Van Acker E, Heireman S, Ghekiere S. Clinical outcomes with a trifocal intraocular lens: a multicenter study. J Refract Surg. 2014 Nov;30(11):762-8. doi: 10.3928/1081597X-20141021-08.
PubMed 25375849Attia MS, Auffarth GU, Khoramnia R, Linz K, Kretz FT. Near and intermediate reading performance of a diffractive trifocal intraocular lens using a reading desk. J Cataract Refract Surg. 2015 Dec;41(12):2707-14. doi: 10.1016/j.jcrs.2015.06.038.
PubMed 26796451Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.
PubMed 26796456Escandon-Garcia S, Ribeiro FJ, McAlinden C, Queiros A, Gonzalez-Meijome JM. Through-Focus Vision Performance and Light Disturbances of 3 New Intraocular Lenses for Presbyopia Correction. J Ophthalmol. 2018 Jan 31;2018:6165493. doi: 10.1155/2018/6165493. eCollection 2018.
PubMed 29651343AcrySof [product information]. Fort Worth TAL, Inc.; 2015
de Vries NE, Webers CA, Montes-Mico R, Tahzib NG, Cheng YY, de Brabander J, Hendrikse F, Nuijts RM. Long-term follow-up of a multifocal apodized diffractive intraocular lens after cataract surgery. J Cataract Refract Surg. 2008 Sep;34(9):1476-82. doi: 10.1016/j.jcrs.2008.05.030.
PubMed 18721706Kinard K, Jarstad A, Olson RJ. Correlation of visual quality with satisfaction and function in a normal cohort of pseudophakic patients. J Cataract Refract Surg. 2013 Apr;39(4):590-7. doi: 10.1016/j.jcrs.2012.11.023. Epub 2013 Feb 6.
PubMed 23395326Monaco G, Gari M, Di Censo F, Poscia A, Ruggi G, Scialdone A. Visual performance after bilateral implantation of 2 new presbyopia-correcting intraocular lenses: Trifocal versus extended range of vision. J Cataract Refract Surg. 2017 Jun;43(6):737-747. doi: 10.1016/j.jcrs.2017.03.037.
PubMed 28732606McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
PubMed 20505205
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Visual Function Following Implantation of Trifocals or Extended
- ClinicalTrials.gov ID
- NCT04900662
- Acronym / sponsor ID
- KEI20190718
- Conditions
- Cataract
- Keywords
- cataract surgery, quality of life, preoperative fasting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is patients receiving cataract surgery at KEI. Sampling is consecutive. No limitation based on gender or sex.
Key inclusion criteria (1 listed)
- any patient receiving cataract surgery at KEI who is able and willing to participate over 18 years old.
Key exclusion criteria (1 listed)
- less than 18, not receiving cataract surgery at KEI, not able or willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
patient burden from preoperative fasting
Time frame: 2019-2021
A questionnaire will be used to assess.
incidence of aspiration or cancellation of surgery because of preoperative fasting violation
Time frame: 2019-2021
A questionnaire will be used to assess.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Background: PubMed 22972061Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
- Background: PubMed 29138533de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
- BackgroundSantos BWL, Cançado JEP, Ferraz VAdS, Campos M. Evaluation of life quality of patients submitted to cataract surgery with implants of monofocal, bifocal and multifocal lenses. Revista Brasileira de Oftalmologia 2014;73:86-92
- Background: PubMed 24143064Gundersen KG, Potvin R. Comparative visual performance with monofocal and multifocal intraocular lenses. Clin Ophthalmol. 2013;7:1979-85. doi: 10.2147/OPTH.S52922. Epub 2013 Oct 7.
- Background: PubMed 25375849Cochener B, Vryghem J, Rozot P, Lesieur G, Chevalier JP, Henry JM, David T, Lesueur L, Gatinel D, Ganem C, Blanckaert J, Van Acker E, Heireman S, Ghekiere S. Clinical outcomes with a trifocal intraocular lens: a multicenter study. J Refract Surg. 2014 Nov;30(11):762-8. doi: 10.3928/1081597X-20141021-08.
- Background: PubMed 26796451Attia MS, Auffarth GU, Khoramnia R, Linz K, Kretz FT. Near and intermediate reading performance of a diffractive trifocal intraocular lens using a reading desk. J Cataract Refract Surg. 2015 Dec;41(12):2707-14. doi: 10.1016/j.jcrs.2015.06.038.
- Background: PubMed 26796456Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.
- Background: PubMed 29651343Escandon-Garcia S, Ribeiro FJ, McAlinden C, Queiros A, Gonzalez-Meijome JM. Through-Focus Vision Performance and Light Disturbances of 3 New Intraocular Lenses for Presbyopia Correction. J Ophthalmol. 2018 Jan 31;2018:6165493. doi: 10.1155/2018/6165493. eCollection 2018.
- BackgroundAcrySof [product information]. Fort Worth TAL, Inc.; 2015
- Background: PubMed 18721706de Vries NE, Webers CA, Montes-Mico R, Tahzib NG, Cheng YY, de Brabander J, Hendrikse F, Nuijts RM. Long-term follow-up of a multifocal apodized diffractive intraocular lens after cataract surgery. J Cataract Refract Surg. 2008 Sep;34(9):1476-82. doi: 10.1016/j.jcrs.2008.05.030.
- Background: PubMed 23395326Kinard K, Jarstad A, Olson RJ. Correlation of visual quality with satisfaction and function in a normal cohort of pseudophakic patients. J Cataract Refract Surg. 2013 Apr;39(4):590-7. doi: 10.1016/j.jcrs.2012.11.023. Epub 2013 Feb 6.
- Background: PubMed 28732606Monaco G, Gari M, Di Censo F, Poscia A, Ruggi G, Scialdone A. Visual performance after bilateral implantation of 2 new presbyopia-correcting intraocular lenses: Trifocal versus extended range of vision. J Cataract Refract Surg. 2017 Jun;43(6):737-747. doi: 10.1016/j.jcrs.2017.03.037.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
RecruitingObservational study
Capella Scientia Development Study
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient burden from preoperative fasting (time frame: 2019-2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900662, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.