Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

• 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: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Tracking Information

• First Submitted Date: September 6, 2017
• First Posted Date: September 12, 2017
• Results First Submitted Date: September 19, 2019
• Results First Posted Date: October 10, 2019
• Last Update Posted Date: October 10, 2019
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: September 27, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 9, 2019)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: October 9, 2019)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
• Official Title: Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cataract

Intervention

• 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®
• Device: AcrySof Monofocal IOL
  AcrySof Monofocal IOL Model SN60AT for single vision
  Other Names:

  • Model SN60AT
  • AcrySof®

Study Arms

• 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).
  Intervention: Device: AcrySof IQ PanOptix Multifocal IOL
• 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).
  Intervention: Device: AcrySof Monofocal IOL

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 30, 2019): 250
• Original Enrollment: Not Provided
• Actual Study Completion Date: September 27, 2018
• Actual Primary Completion Date: September 27, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03280108
• Other Study ID Numbers: ILH297-C001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Alcon Research
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Alcon Research
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Study Director: Alcon Research; Alcon Research

• PRS Account: Alcon Research
• Verification Date: October 2019