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Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04196569
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cataract Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Group/Cohort 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





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196569


Contacts
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Contact: Susan Herder, BA, PA-C 646-962-4118 herders@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Susan Herder, BA, PA-C    646-962-4118    herders@med.cornell.edu   
Principal Investigator: Ashley Brissette, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Alcon Research
Investigators
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Principal Investigator: Ashley Brissette, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04196569    
Other Study ID Numbers: 19-05020251
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Weill Medical College of Cornell University:
trifocal lens
trifocal intraocular lens
aberrometry
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases