Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

NCT04196569 | Completed

• 1 other identifier: 19-05020251
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Keywords

trifocal lens; trifocal intraocular lens; aberrometry

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Spectacle independence for distance, intermediate and near

  1 month post-cataract surgery

• Spectacle independence for distance, intermediate and near

  3 months post-cataract surgery

• Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)

  1 month post-cataract surgery

• Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)

  3 months post-cataract surgery

• Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target

  3 months post-cataract surgery

Study Arms (1)

trifocal intraocular lens

Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses

Interventions

Alcon Trifocal and Trifocal Toric Intraocular Lenses DEVICE

Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics: TFAT30, TFAT40, TFAT50, TFAT60

trifocal intraocular lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a diagnosis of visually-significant cataracts who meet the inclusion and exclusion criteria will be eligible for participation in this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Alcon Research: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Ashley Brissette, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: December 12, 2019
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)