Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Cataract Clinical Trial

Official title:

Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280108
• Other study ID #: ILH297-C001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: September 27, 2018

Study information

• Verified date: October 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof IQ PanOptix Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
• AcrySof Monofocal IOL
AcrySof Monofocal IOL Model SN60AT for single vision

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Fresno	California
United States	Alcon Investigative Site	Houston	Texas
United States	Alcon Investigative Site	Hurst	Texas
United States	Alcon Investigative Site	Mount Dora	Florida
United States	Alcon Investigative Site	Mount Pleasant	South Carolina
United States	Alcon Investigative Site	Nacogdoches	Texas
United States	Alcon Investigative Site	Nashville	Tennessee
United States	Alcon Investigative Site	Norfolk	Virginia
United States	Alcon Investigative Site	Panama City	Florida
United States	Alcon Investigative Site	Poughkeepsie	New York
United States	Alcon Investigative Site	Salt Lake City	Utah
United States	Alcon Investigative Site	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 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 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.	Month 6 (Day 120-180), post second eye implantation
Secondary	Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire	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.	Month 6 (Day 120-180), post second eye implantation
Secondary	Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)	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.	Month 6 (Day 120-180), post second eye implantation
Secondary	Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID	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.	Month 6 (Day 120-180), post second eye implantation