Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

NCT ID: NCT06041139

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2024-04-16

Brief Summary

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.

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.

Conditions

Pseudophakia

Study Design

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

Study Groups

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.

Visual Acuity

Intervention Type: DIAGNOSTIC_TEST

Measurement of distance, intermediate and near visual acuity.

Defocus Curve

Intervention Type: DIAGNOSTIC_TEST

Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.

Halo and Glare testing

Intervention Type: DIAGNOSTIC_TEST

Measurement to quantify degree of visual loss caused by either halo and/or glare.

Patient Questionnaires

Intervention Type: OTHER

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.

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.

Visual Acuity

Intervention Type: DIAGNOSTIC_TEST

Measurement of distance, intermediate and near visual acuity.

Defocus Curve

Intervention Type: DIAGNOSTIC_TEST

Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.

Halo and Glare testing

Intervention Type: DIAGNOSTIC_TEST

Measurement to quantify degree of visual loss caused by either halo and/or glare.

Patient Questionnaires

Intervention Type: OTHER

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.

Interventions

Visual Acuity

Measurement of distance, intermediate and near visual acuity.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Halo and Glare testing

Measurement to quantify degree of visual loss caused by either halo and/or glare.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

Other Intervention Names

VS Halo & Glare (visu-med.com); IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Berkeley Eye Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morgan Micheletti, MD

Role: PRINCIPAL_INVESTIGATOR

Berkeley Eye Center

Locations

Berkeley Eye Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

69881171

Identifier Type: -

Identifier Source: org_study_id