Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

NCT03280108 | Completed Results FDA Device

• 1 other identifier: ILH297-C001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 12

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.

Conditions

Cataract

Keywords

Intraocular lens; IOL

Outcome Measures

Primary Outcomes (7)

• Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)

  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.

  Month 6 (Day 120-180), post second eye implantation

• Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)

  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.

  Month 6 (Day 120-180), post second eye implantation

• Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye

  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.

  Up to Month 6 (Day 120-180), post second eye implantation

• Mean Photopic Without Glare Binocular Distance Contrast Sensitivity

  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.

  Month 6 (Day 120-180), post second eye implantation

• Mean Photopic With Glare Binocular Distance Contrast Sensitivity

  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.

  Month 6 (Day 120-180), post second eye implantation

• Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity

  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.

  Month 6 (Day 120-180), post second eye implantation

• Mean Mesopic With Glare Binocular Distance Contrast Sensitivity

  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.

  Month 6 (Day 120-180), post second eye implantation

Secondary Outcomes (4)

• Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)

  Month 6 (Day 120-180), post second eye implantation

• Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire

  Month 6 (Day 120-180), post second eye implantation

• Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)

  Month 6 (Day 120-180), post second eye implantation

• Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID

  Month 6 (Day 120-180), post second eye implantation

Study Arms (2)

Multifocal IOL

EXPERIMENTAL

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

Monofocal IOL

ACTIVE COMPARATOR

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

Interventions

AcrySof IQ PanOptix Multifocal IOL DEVICE

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision

Also known as: Model TFNT00, AcrySof® IQ PanOptix®

Multifocal IOL

AcrySof Monofocal IOL DEVICE

AcrySof Monofocal IOL Model SN60AT for single vision

Also known as: Model SN60AT, AcrySof®

Monofocal IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (12)

Alcon Investigative Site

Fresno, California, 93720, United States

Location

Alcon Investigative Site

Mt. Dora, Florida, 32757, United States

Location

Alcon Investigative Site

Panama City, Florida, 32405, United States

Location

Alcon Investigative Site

Poughkeepsie, New York, 12603, United States

Location

Alcon Investigative Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Alcon Investigative Site

Sioux Falls, South Dakota, 57108, United States

Location

Alcon Investigative Site

Nashville, Tennessee, 37205, United States

Location

Alcon Investigative Site

Houston, Texas, 77027, United States

Location

Alcon Investigative Site

Hurst, Texas, 76054, United States

Location

Alcon Investigative Site

Nacogdoches, Texas, 75965, United States

Location

Alcon Investigative Site

Salt Lake City, Utah, 84107, United States

Location

Alcon Investigative Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Expert Clinical Project Lead, CDMA Surgical
• Organization: Alcon Research

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon Research

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 12, 2017
• Study Start: November 1, 2017
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: October 10, 2019
• Results First Posted: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)