Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Background:

• The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions.
• A J&J-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL.

Hypothesis:

• Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare, haloes, and/or starbursts.

Unmet Medical Need:

• There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOF/Bifocal technology in the United States.

Study Overview

• Status: Recruiting
• Conditions: Pseudophakia
• Intervention / Treatment: Diagnostic test: Visual Acuity; Diagnostic test: Defocus Curve; Diagnostic test: Halo and Glare testing; Other: Patient Questionnaires

Detailed Description

• This is a non-interventional single center, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery.
• There will be 155 subjects enrolled in each arm (310 subjects total).
• Consecutive screening will be used for enrollment beginning from the first bilateral IOL implanted.
• All testing will be at a single site with subjects coming from 4 surgeons (all use similar surgical technique) at that site.
• Each surgeon will contribute a minimum of ten subjects per arm.
• Subjects will be assessed post-operatively during a minimum of five months after their second-eye surgery.
• Binocular defocus curves will be performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
• Self-reporting of visual complaints will be assessed.
• IOLSAT (IOL Satisfaction) and QUVID (Quality of Vision After Surgery) questionnaire will be administered at the study visit.
• Halo and Glare simulator VS Halo & Glare (visu-med.com) will be administered at the study visit.
• All visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked.
• PanOptix subjects will have been implanted with the toric and non-toric models.
• Synergy subjects will have been implanted with the toric and non-toric models.
• Demographic data will be collected to match the groups as closely as possible.

• Study Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

• Study Contact: Name: Diana Hill; Phone Number: 713-620-7640; Email: diana.hill@berkeleyeye.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77027
      • Recruiting
      • Berkeley Eye Center
      • Contact: Diana Hill; Phone Number: 713-620-7640; Email: diana.hill@berkeleyeye.com
      • Principal Investigator: Morgan Micheletti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with healthy eyes and uncomplicated bilateral implantation of Panoptix IOLs or Synergy IOLs.

Description

Inclusion Criteria:

• Are willing and able to understand and sign an informed consent
• Are willing and able to complete all required study visits
• Are more than 40 years of age
• Patient diagnosed with cataracts both eyes and underwent uncomplicated cataract surgeries
• Patients with bilateral PanOptix (toric or non-toric)
• Patients with bilateral Synergy (toric or non-toric)
• Post-op best Corrected distance Visual Acuity for each eye is logMAR 0.1 (20/25) or better after cataract removal.
• Post-op residual refractive error +0.50 - -0.50 SE with ≤ 0.75 residual refractive astigmatism in each eye
• Minimum of two weeks post Yttrium Aluminum Garnet capsulotomy to treat posterior capsular opacification

Exclusion Criteria:

• Corneal dystrophies or degenerations
• Failure to return for follow up at designed intervals.
• Any conditions that might affect cataract removal (pseudoexfoliation, posterior polar cataract, Flomax, etc.)
• Any conditions during surgery that might prolong the cataract removal (capsular tear, inadequate pupil dilation, etc.)
• Strabismus with or without amblyopia in either eye
• Previous ocular surgery of any kind
• History of retinal detachment
• Any corneal abnormality, other than regular corneal astigmatism (as determined by corneal topography) that in the opinion of the investigator would confound the outcome(s) of the study
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that in the opinion of the investigator is clinically significant
• Subjects with glaucoma
• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, etc)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alcon PanOptix; Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.	Diagnostic test: Visual Acuity; Measurement of distance, intermediate and near visual acuity.; Diagnostic test: Defocus Curve; Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.; Diagnostic test: Halo and Glare testing; Measurement to quantify degree of visual loss caused by either halo and/or glare.; Other Names: VS Halo & Glare (visu-med.com); Other: Patient Questionnaires; Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.; Other Names: IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire
Johnson & Johnson Synergy; Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.	Diagnostic test: Visual Acuity; Measurement of distance, intermediate and near visual acuity.; Diagnostic test: Defocus Curve; Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.; Diagnostic test: Halo and Glare testing; Measurement to quantify degree of visual loss caused by either halo and/or glare.; Other Names: VS Halo & Glare (visu-med.com); Other: Patient Questionnaires; Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.; Other Names: IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular DCNVA (distance corrected near visual acuity) of Trifocal (Alcon PanOptix)	Binocular DCNVA of Trifocal (Alcon PanOptix). Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively
Binocular DCNVA of EDOF (extended depth of focus)/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm	Binocular DCNVA of EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular BCDVA measured at 4m.	Binocular BCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively
Binocular DCIVA measured at 60cm.	Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively
Binocular UCDVA measured at 4m.	Binocular UCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively
Binocular UCIVA measured at 60cm.	Binocular UCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively
Binocular UCNVA measured at 40cm.	Binocular UCNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively
Binocular target corrected defocus curve	Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively
Patient self-reported visual disturbances.	Patient self-reported visual disturbances will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Patient reported satisfaction by IOLSAT questionnaire.	Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Patient reported satisfaction by QUVID questionnaire.	Patient reported satisfaction by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Post operative refraction.	Post operative refraction. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectacle independence utilizing the IOLSAT.	Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Halo will be reported.	Halo will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Glare will be reported.	Glare will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Binocular DCNVA at 33cm.	Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.	3 months post operatively

Collaborators and Investigators

• Sponsor: Berkeley Eye Center
• Investigators: Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pseudophakia; Alcon PanOptix; Johnson & Johnson Tecnis Synergy
• Additional Relevant MeSH Terms: Pseudophakia
• Other Study ID Numbers: 69881171

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: Yes