Clinical trial NCT04196569: Trifocal Intraocular Lens (IOL) Aberrometry Outcomes
Official title: Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: trifocal lens
trifocal intraocular lens
aberrometry
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2019-12-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of visually-significant cataracts who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Brief summary: The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.


Eligibility criteria: Inclusion Criteria:

* Able to consent to study and cataract surgery
* Visually significant cataract
* Potential post-operative visual acuity of 20/25 or better
* Age 18 years or older

Exclusion Criteria:

* Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss
* Irregular astigmatism
* Prior corneal refractive surgery

Primary outcomes:
measure: Percentage of spectacle independence (overall)
timeFrame: 1 month post-cataract surgery
measure: Percentage spectacle independence (overall)
timeFrame: 3 months post-cataract surgery
Secondary outcomes:
measure: Spectacle independence for distance, intermediate and near
timeFrame: 1 month post-cataract surgery
measure: Spectacle independence for distance, intermediate and near
timeFrame: 3 months post-cataract surgery
measure: Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)
timeFrame: 1 month post-cataract surgery
measure: Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)
timeFrame: 3 months post-cataract surgery
measure: Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target
timeFrame: 3 months post-cataract surgery
measure: Subject satisfaction
timeFrame: 3 months post-cataract surgery
measure: Uncorrected binocular and monocular visual acuity at all distances
timeFrame: 3 months post-cataract surgery
measure: Distribution of residual refractive error
timeFrame: 3 months post-cataract surgery
measure: Contrast sensitivity (binocular)
timeFrame: 1 month post-cataract surgery
measure: Contrast sensitivity (binocular)
timeFrame: 3 months post-cataract surgery
measure: Percentage of subjects with <=0.50 D of refractive cylinder
timeFrame: 1 month post-cataract surgery
measure: Percentage of subjects with <=0.50 D of refractive cylinder
timeFrame: 3 months post-cataract surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ashley Brissette, MD
role: PRINCIPAL_INVESTIGATOR
References: