Cataract
Conditions
Keywords
trifocal lens, trifocal intraocular lens, aberrometry
Brief summary
The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.
Interventions
DEVICEAlcon Trifocal and Trifocal Toric Intraocular Lenses
Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics: TFAT30, TFAT40, TFAT50, TFAT60
Sponsors
Alcon Research
Weill Medical College of Cornell University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of spectacle independence (overall) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target | 3 months post-cataract surgery | This will be measured by visual acuity |
| Subject satisfaction | 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. |
| Uncorrected binocular and monocular visual acuity at all distances | 3 months post-cataract surgery | This will be measured by visual acuity |
| Spectacle independence for distance, intermediate and near | 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. |
| Contrast sensitivity (binocular) | 1 month post-cataract surgery | This will be measured by contrast sensitivity testing |
| Percentage of subjects with <=0.50 D of refractive cylinder | 1 month post-cataract surgery | This will be measured by refractive error |
| Distribution of residual refractive error | 3 months post-cataract surgery | This will be measured by refractive error |
| Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE) | 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. |
Countries
United States
Outcome results
None listed