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N/A N=30

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

Cataract

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants Who Have Spectacle Independence — 27 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Panoptix (Device)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Gainesville Eye Associates
Primary completion
Mar 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Have Spectacle Independence
27
SECONDARY
Binocular Uncorrected Distance Visual Acuity
.09
SECONDARY
Binocular Uncorrected Intermediate Visual Acuity
SECONDARY
Binocular Uncorrected Near Visual Acuity
.03
SECONDARY
Binocular Best-corrected Distance Visual Acuity
.02
SECONDARY
Binocular Distance-corrected Intermediate Visual Acuity
-.02
SECONDARY
Binocular Distance-corrected Near Visual Acuity
-.01
SECONDARY
Spherical Equivalent Refraction
-.02
SECONDARY
Residual Refractive Cylinder
0.21
SECONDARY
Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup
21

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04126187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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