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

NCT04126187 | Completed Results FDA Device

• 1 other identifier: CB-19-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Keywords

Panoptix; Trifocal IOL; Multifocal IOL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Binocular Uncorrected Distance Visual Acuity

  3 months

• Binocular Uncorrected Intermediate Visual Acuity

  3 months

• Binocular Uncorrected Near Visual Acuity

  3 months

• Binocular Best-corrected Distance Visual Acuity

  3 months

• Binocular Distance-corrected Intermediate Visual Acuity

  3 months

Study Arms (1)

Panoptix

Bilateral implantation of the Panoptix trifocal IOL

Device: Panoptix

Interventions

Panoptix DEVICE

Panoptix trifocal intraocular lens (IOL)

Panoptix

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gainesville Eye Associates: lead
• Science in Vision: collaborator

Study Sites (1)

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

Location

Related Publications (1)

• 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.

  PMID: 28341605 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Clayton Blehm, MD
• Organization: Gainesville Eye Associates

claytonblehm@gmail.com

17705324444

Study Officials

• Clayton G Blehm, MD

  Gainesville Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: May 14, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: September 21, 2023
• Results First Posted: August 11, 2021

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)