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

NCT04128514 | Terminated FDA Device

• 1 other identifier: BF-19-001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

Toric IOL; Panoptix; multifocal IOL; trifocal IOL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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)

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

Interventions

Panoptix Toric DEVICE

Cataract surgery and IOL implantation

Enrolled subjects

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 reducing their dependence on spectacles at all distances, and who are 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 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

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, 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.

Sponsors & Collaborators

• Eye Center of North Florida: lead
• Science in Vision: collaborator

Study Sites (1)

Eye Center of North Florida

Panama City, Florida, 32409, United States

Location

Related Publications (2)

• 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

• 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.

  PMID: 30612749 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Bret Fisher, MD

  Eye Center of North Florida

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 16, 2019
• Study Start: October 11, 2019
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (1)