Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

Completed

• Conditions: Cataract
• Interventions: Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses

• Registration Number: NCT04196569
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study Start: 2019-12-12
• Study First Posted: 2019-12-12
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
trifocal intraocular lens	Alcon Trifocal and Trifocal Toric Intraocular Lenses	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Distribution of residual refractive error	3 months post-cataract surgery	This will be measured by refractive error
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.
Percentage of subjects with <=0.50 D of refractive cylinder	3 months post-cataract surgery	This will be measured by refractive error
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
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
Contrast sensitivity (binocular)	3 months post-cataract surgery	This will be measured by contrast sensitivity testing

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States