Trifocal Intraocular Lens (IOL) Aberrometry Outcomes
Study Details
Study Description
Brief Summary
The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| trifocal intraocular lens
|
Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses
Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics:
TFAT30, TFAT40, TFAT50, TFAT60
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- Spectacle independence for distance, intermediate and near [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.
- 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.
- Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE) [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.
- 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
- Distribution of residual refractive error [3 months post-cataract surgery]
This will be measured by refractive error
- Contrast sensitivity (binocular) [1 month post-cataract surgery]
This will be measured by contrast sensitivity testing
- Contrast sensitivity (binocular) [3 months 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
- Percentage of subjects with <=0.50 D of refractive cylinder [3 months post-cataract surgery]
This will be measured by refractive error
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medicine | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- Alcon Research
Investigators
- Principal Investigator: Ashley Brissette, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-05020251