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Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

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ClinicalTrials.gov Identifier: NCT03280108
Recruitment Status : Completed
First Posted : September 12, 2017
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof IQ PanOptix Multifocal IOL Device: AcrySof Monofocal IOL Not Applicable

Detailed Description:
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
 Device: AcrySof IQ PanOptix Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
Other Names:
  • Model TFNT00
  • AcrySof® IQ PanOptix®
Active Comparator: Monofocal IOL
AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
 Device: AcrySof Monofocal IOL
AcrySof Monofocal IOL Model SN60AT for single vision
Other Names:
  • Model SN60AT
  • AcrySof®


Outcome Measures
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Primary Outcome Measures :
  1. Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

  2. Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

  3. Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye [ Time Frame: Up to Month 6 (Day 120-180), post second eye implantation ]
    The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.

  4. Mean Photopic Without Glare Binocular Distance Contrast Sensitivity [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

  5. Mean Photopic With Glare Binocular Distance Contrast Sensitivity [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

  6. Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

  7. Mean Mesopic With Glare Binocular Distance Contrast Sensitivity [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.


Secondary Outcome Measures :
  1. Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

  2. Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.

  3. Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.

  4. Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID [ Time Frame: Month 6 (Day 120-180), post second eye implantation ]
    Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
  • Clear intraocular media other than cataract in both eyes.
  • Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.

Exclusion Criteria:

  • Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema
  • Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)
  • Glaucoma (uncontrolled or controlled with medication)
  • Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)
  • Pregnant or lactating
  • Expected to require a second surgical intervention or retinal laser treatment.
Contacts and Locations
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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): NCT03280108


Locations
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United States, California
Alcon Investigative Site
Fresno, California, United States, 93720
United States, Florida
Alcon Investigative Site
Mount Dora, Florida, United States, 32757
Alcon Investigative Site
Panama City, Florida, United States, 32405
United States, New York
Alcon Investigative Site
Poughkeepsie, New York, United States, 12603
United States, South Carolina
Alcon Investigative Site
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Alcon Investigative Site
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Alcon Investigative Site
Nashville, Tennessee, United States, 37205
United States, Texas
Alcon Investigative Site
Houston, Texas, United States, 77027
Alcon Investigative Site
Hurst, Texas, United States, 76054
Alcon Investigative Site
Nacogdoches, Texas, United States, 75965
United States, Utah
Alcon Investigative Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Alcon Investigative Site
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon Research Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] March 28, 2018
Statistical Analysis Plan  [PDF] September 26, 2018

More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03280108    
Other Study ID Numbers: ILH297-C001
First Posted: September 12, 2017    Key Record Dates
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019
Last Verified: October 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
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Alcon Research:
Intraocular lens
IOL
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases