Spectacle Independence and Overall Satisfaction With AcrySof® Panoptix® Toric Intraocular Lens

Spectacle Independence and Overall Satisfaction With Bilateral Implantation of the AcrySof® Panoptix® Toric Intraocular Lens

The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric intraocular lens (IOL) after uneventful cataract surgery.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: Panoptix Toric

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 and a quality of life questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Florida
    • Panama City, Florida, United States, 32409
      • Eye Center of North Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are 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 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 toric IOL in the approved range (T3-T6) 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, DSAEK, lamellar keratoplasty)
• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
• Diabetic retinopathy
• Macular pathology (e.g. ARMD, ERM)
• 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 any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enrolled subjects; Subjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are appropriate candidates for multifocal lens implantation. The Acrysof (R) Panoptix (R) Toric intraocular lens will be implanted in both eyes of subjects.	Device: Panoptix Toric; Cataract surgery and IOL implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectacle independence - emmetropia	Percent of patients with ≤ 0.5D of refractive cylinder and ≤ 0.50D of absolute residual spherical equivalent refraction postoperatively who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular uncorrected distance visual acuity	Binocular distance visual acuity	3 months
Binocular uncorrected intermediate visual acuity	Binocular intermediate visual acuity	3 months
BInocular uncorrected near visual acuity	Binocular near visual acuity	3 months
Binocular best-corrected distance visual acuity	Binocular best-corrected distance visual acuity	3 months
Binocular distance-corrected intermediate visual acuity	Binocular distance-corrected intermediate visual acuity	3 months
Binocular distance-corrected near visual acuity	Binocular distance-corrected near visual acuity	3 months
Spherical equivalent refraction	Spherical equivalent refraction	3 months
Residual astigmatism	Residual astigmatism	3 months
Uncorrected preferred reading distance	Uncorrected preferred reading distance	3 months
Monocular corrected distance visual acuity	Monocular corrected distance visual acuity	3 months
Spectacle independence - overall	Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")	3 months
Binocular uncorrected visual acuity at preferred reading distance	Binocular uncorrected visual acuity at preferred reading distance	3 months
VFQ-14	Questionnaire responses on VFQ-14 visual function questionnaire	3 months
Choose lens again	Percent of patients who would choose this lens modality again.	3 months

Collaborators and Investigators

• Sponsor: Eye Center of North Florida
• Collaborators: Science in Vision
• Investigators: Principal Investigator: Bret Fisher, MD, Eye Center of North Florida

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.
• Akman A, Asena L, Ozturk C, Gur Gungor S. Evaluation of quality of life after implantation of a new trifocal intraocular lens. J Cataract Refract Surg. 2019 Feb;45(2):130-134. doi: 10.1016/j.jcrs.2018.12.003. Epub 2019 Jan 3.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Toric IOL; multifocal IOL; Panoptix; trifocal IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: BF-19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: No current plans to share data, but if shared, any shared outcomes data will be de-identified before release.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes