Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

NCT06041139 | Completed Results FDA Device

• 1 other identifier: 69881171
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudophakia

Keywords

Pseudophakia; Alcon PanOptix; Johnson & Johnson Tecnis Synergy

Outcome Measures

Primary Outcomes (1)

• Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm

  Binocular DCNVA 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 Outcomes (9)

• Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.

  3 months post operatively

• Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.

  3 months post operatively

• Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.

  3 months post operatively

• Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.

  3 months post operatively

• Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.

  3 months post operatively

Other Outcomes (2)

• Spectacle Independence Utilizing the IOLSAT.

  3 months post operatively

• Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.

  3 months post operatively

Study Arms (2)

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; Diagnostic Test: Defocus Curve; Diagnostic Test: Halo and Glare testing; Other: Patient Questionnaires

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; Diagnostic Test: Defocus Curve; Diagnostic Test: Halo and Glare testing; Other: Patient Questionnaires

Interventions

Visual Acuity DIAGNOSTIC_TEST

Measurement of distance, intermediate and near visual acuity.

Alcon PanOptix; Johnson & Johnson Synergy

Defocus Curve 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.

Alcon PanOptix; Johnson & Johnson Synergy

Halo and Glare testing DIAGNOSTIC_TEST

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

Also known as: VS Halo & Glare (visu-med.com)

Alcon PanOptix; Johnson & Johnson Synergy

Patient Questionnaires 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.

Also known as: IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire

Alcon PanOptix; Johnson & Johnson Synergy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Berkeley Eye Center: lead

Study Sites (1)

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Pseudophakia

Interventions

Visual Acuity; Glare

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena; Light; Optical Phenomena; Physical Phenomena

Results Point of Contact

• Title: Tetiana Huff
• Organization: Berkeley Eye Center

tetiana.huff@berkeleyeye.com

713-620-7640

Study Officials

• Morgan Micheletti, MD

  Berkeley Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: September 18, 2023
• Study Start: September 12, 2022
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)