Evaluation of Quality of Vision and Spectacle Independence With the AcrySof® Panoptix® Intraocular Lens
NCT ID: NCT04124952
Last Updated: 2023-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
30 participants
OBSERVATIONAL
2019-10-03
2021-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Panoptix
Patients bilaterally implanted with the Panoptix intraocular lens.
Panoptix
Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Interventions
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Panoptix
Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Eligibility Criteria
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Inclusion 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
* Corneal pathology (e.g. scar, dystrophy, pterygium, 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 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.
40 Years
ALL
Yes
Sponsors
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Science in Vision
OTHER
SightTrust Eye Institute
OTHER
Responsible Party
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Principal Investigators
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Andrew C Shatz, MD
Role: PRINCIPAL_INVESTIGATOR
SightTrust Eye Institute
Locations
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SightTrust Eye Institute
Sunrise, Florida, United States
Countries
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References
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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.
McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AS-19-001
Identifier Type: -
Identifier Source: org_study_id