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OpenTrials
Completed

NCT Number: NCT06041139

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Berkeley Eye Center

Houston, Texas, 77027, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Visual Acuity

Diagnostic Test

Measurement of distance, intermediate and near visual acuity.

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.

Halo and Glare testing

Diagnostic Test

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

Other names: VS Halo & Glare (visu-med.com)

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.

Other names: IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire

Primary outcomes

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

    Time frame: 3 months post operatively

    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.

Secondary outcomes

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

    Time frame: 3 months post operatively

    Binocular CDVA 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.

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

    Time frame: 3 months post operatively

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

    Time frame: 3 months post operatively

    Binocular UDVA 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.

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

    Time frame: 3 months post operatively

    Binocular UIVA 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.

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

    Time frame: 3 months post operatively

    Binocular UNVA 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.

  6. Binocular Target Corrected Defocus Curve

    Time frame: 3 months post operatively

    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.

  7. Patient Reported Satisfaction by IOLSAT Questionnaire.

    Time frame: 3 months post operatively

    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. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage.

  8. Patient Reported Dysphotopsias Questionnaire (QUVID).

    Time frame: 3 months post operatively

    Patient reported disphotopsias 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. The percentage of subjects that answered "Never" for frequency are provided.

  9. Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).

    Time frame: 3 months post operatively

    Post operative refraction. 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.

Other outcomes

  1. Spectacle Independence Utilizing the IOLSAT.

    Time frame: 3 months post operatively

    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. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".

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

    Time frame: 3 months post operatively

    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.

Sponsors and collaborators

Lead sponsor

Berkeley Eye Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2023
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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