Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Sponsor
Berkeley Eye Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06041139
Collaborator
(none)
310
1
14.6
21.2

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
310 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
Actual Study Start Date :
Sep 12, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Binocular DCNVA (distance corrected near visual acuity) of Trifocal (Alcon PanOptix) [through study completion, an average of 1 year]

      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.

    2. Binocular DCNVA of EDOF (extended depth of focus)/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm [through study completion, an average of 1 year]

      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.

    Secondary Outcome Measures

    1. Binocular BCDVA measured at 4m. [through study completion, an average of 1 year]

      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.

    2. Binocular DCIVA measured at 60cm. [through study completion, an average of 1 year]

      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 UCDVA measured at 4m. [through study completion, an average of 1 year]

      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.

    4. Binocular UCIVA measured at 60cm. [through study completion, an average of 1 year]

      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.

    5. Binocular UCNVA measured at 40cm. [through study completion, an average of 1 year]

      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.

    6. Binocular target corrected defocus curve [through study completion, an average on 1 year]

      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 self-reported visual disturbances. [through study completion, an average of 1 year]

      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.

    8. Patient reported satisfaction by IOLSAT questionnaire. [through study completion, an average of 1 year]

      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.

    9. Patient reported satisfaction by QUVID questionnaire. [through study completion, an average of 1 year]

      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.

    10. Post operative refraction. [through study completion, an average of 1 year]

      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.

    Other Outcome Measures

    1. Spectacle independence utilizing the IOLSAT. [through study completion, an average of 1 year]

      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.

    2. Halo will be reported. [through study completion, an average of 1 year]

      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. Glare will be reported. [through study completion, an average of 1 year]

      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.

    4. Binocular DCNVA at 33cm. [through study completion, an average of 1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Berkeley Eye Center Houston Texas United States 77027

    Sponsors and Collaborators

    • Berkeley Eye Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Berkeley Eye Center
    ClinicalTrials.gov Identifier:
    NCT06041139
    Other Study ID Numbers:
    • 69881171
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Berkeley Eye Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2023