AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study

The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Panoptix

Detailed Description

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Gainesville Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects ≥40 years of age presenting for cataract surgery who are interested in spectacle lens freedom and considered appropriate candidates for multifocal lens implantation.

Description

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option
• Gender: Males and Females.
• Age: 40 or older.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.
• Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
• Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens.
• Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Irregular astigmatism (e.g. keratoconus)
• Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
• Monocular status (e.g. amblyopia)
• Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
• Diabetic retinopathy
• Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
• History of retinal detachment
• 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, and any other such disease or illness), that are known to affect postoperative visual acuity.
• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Panoptix; Bilateral implantation of the Panoptix trifocal IOL	Device: Panoptix; Panoptix trifocal intraocular lens (IOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Have Spectacle Independence	Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time")	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Uncorrected Near Visual Acuity	Binocular logMAR uncorrected near visual acuity	3 months
Binocular Distance-corrected Near Visual Acuity	Binocular logMAR distance-corrected near visual acuity	3 months
Spherical Equivalent Refraction	Spherical equivalent refraction in diopters	3 months
Residual Refractive Cylinder	Residual refractive cylinder in diopters	3 months
Binocular Uncorrected Distance Visual Acuity	Binocular uncorrected distance visual acuity in logMAR	3 months
Binocular Uncorrected Intermediate Visual Acuity	Binocular uncorrected intermediate visual acuity in logMAR	3 months
Binocular Best-corrected Distance Visual Acuity	Binocular logMAR best-corrected distance visual acuity	3 months
Binocular Distance-corrected Intermediate Visual Acuity	Binocular distance-corrected logMAR intermediate visual acuity	3 months
Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup	Spectacle independence of subjects that hit refractive target within 0.5 diopters (D) spherical equivalent refraction	3 months

Collaborators and Investigators

• Sponsor: Gainesville Eye Associates
• Collaborators: Science in Vision
• Investigators: Principal Investigator: Clayton G Blehm, MD, Gainesville Eye Associates

Publications and helpful links

General Publications

• Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Trifocal IOL; Panoptix; Multifocal IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CB-19-002

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
• product manufactured in and exported from the U.S.: Yes