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Completed

NCT Number: NCT04196569

Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medicine

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcon Trifocal and Trifocal Toric Intraocular Lenses

Device

Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics:

TFAT30, TFAT40, TFAT50, TFAT60

Primary outcomes

  1. Percentage of spectacle independence (overall)

    Time frame: 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.

  2. Percentage spectacle independence (overall)

    Time frame: 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 outcomes

  1. Spectacle independence for distance, intermediate and near

    Time frame: 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.

  2. Spectacle independence for distance, intermediate and near

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 3 months post-cataract surgery

    This will be measured by visual acuity

  6. Subject satisfaction

    Time frame: 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.

  7. Uncorrected binocular and monocular visual acuity at all distances

    Time frame: 3 months post-cataract surgery

    This will be measured by visual acuity

  8. Distribution of residual refractive error

    Time frame: 3 months post-cataract surgery

    This will be measured by refractive error

  9. Contrast sensitivity (binocular)

    Time frame: 1 month post-cataract surgery

    This will be measured by contrast sensitivity testing

  10. Contrast sensitivity (binocular)

    Time frame: 3 months post-cataract surgery

    This will be measured by contrast sensitivity testing

  11. Percentage of subjects with <=0.50 D of refractive cylinder

    Time frame: 1 month post-cataract surgery

    This will be measured by refractive error

  12. Percentage of subjects with <=0.50 D of refractive cylinder

    Time frame: 3 months post-cataract surgery

    This will be measured by refractive error

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2019
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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