Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Percentage of spectacle independence (overall)
Study Overview
Brief Summary
The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of spectacle independence (overall)
Time Frame: 1 month post-cataract surgery
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Percentage spectacle independence (overall)
Time Frame: 3 months post-cataract surgery
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Secondary Outcomes
- Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)(3 months post-cataract surgery)
- Distribution of residual refractive error(3 months post-cataract surgery)
- Spectacle independence for distance, intermediate and near(3 months post-cataract surgery)
- Percentage of subjects with <=0.50 D of refractive cylinder(3 months post-cataract surgery)
- Subject satisfaction(3 months post-cataract surgery)
- Uncorrected binocular and monocular visual acuity at all distances(3 months post-cataract surgery)
- Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target(3 months post-cataract surgery)
- Contrast sensitivity (binocular)(3 months post-cataract surgery)