Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

Cataract Clinical Trial

Official title:

Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196569
• Other study ID #: 19-05020251
• Status: Completed
• Start date: December 12, 2019
• Est. completion date: September 13, 2022

Study information

• Verified date: December 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Alcon Trifocal and Trifocal Toric Intraocular Lenses
Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics: TFAT30, TFAT40, TFAT50, TFAT60

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of spectacle independence (overall)	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.	1 month post-cataract surgery
Primary	Percentage spectacle independence (overall)	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.	3 months post-cataract surgery
Secondary	Spectacle independence for distance, intermediate and near	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.	1 month post-cataract surgery
Secondary	Spectacle independence for distance, intermediate and near	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.	3 months post-cataract surgery
Secondary	Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)	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.	1 month post-cataract surgery
Secondary	Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)	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.	3 months post-cataract surgery
Secondary	Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target	This will be measured by visual acuity	3 months post-cataract surgery
Secondary	Subject satisfaction	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.	3 months post-cataract surgery
Secondary	Uncorrected binocular and monocular visual acuity at all distances	This will be measured by visual acuity	3 months post-cataract surgery
Secondary	Distribution of residual refractive error	This will be measured by refractive error	3 months post-cataract surgery
Secondary	Contrast sensitivity (binocular)	This will be measured by contrast sensitivity testing	1 month post-cataract surgery
Secondary	Contrast sensitivity (binocular)	This will be measured by contrast sensitivity testing	3 months post-cataract surgery
Secondary	Percentage of subjects with <=0.50 D of refractive cylinder	This will be measured by refractive error	1 month post-cataract surgery
Secondary	Percentage of subjects with <=0.50 D of refractive cylinder	This will be measured by refractive error	3 months post-cataract surgery