Clinical trial NCT04126187: AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study
Official title: AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Panoptix
Trifocal IOL
Multifocal IOL
Lead sponsor: Gainesville Eye Associates
Sponsor class: OTHER
Collaborators: name: Science in Vision
First posted: 2019-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

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.

Primary outcomes:
measure: Number of Participants Who Have Spectacle Independence
timeFrame: 3 months
Secondary outcomes:
measure: Binocular Uncorrected Distance Visual Acuity
timeFrame: 3 months
measure: Binocular Uncorrected Intermediate Visual Acuity
timeFrame: 3 months
measure: Binocular Uncorrected Near Visual Acuity
timeFrame: 3 months
measure: Binocular Best-corrected Distance Visual Acuity
timeFrame: 3 months
measure: Binocular Distance-corrected Intermediate Visual Acuity
timeFrame: 3 months
measure: Binocular Distance-corrected Near Visual Acuity
timeFrame: 3 months
measure: Spherical Equivalent Refraction
timeFrame: 3 months
measure: Residual Refractive Cylinder
timeFrame: 3 months
measure: Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup
timeFrame: 3 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Gainesville Eye Associates
state: Georgia
Study officials:
affiliation: Gainesville Eye Associates
name: Clayton G Blehm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.