Clinical trial NCT03280108: Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Official title: Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular lens
IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 250
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye
timeFrame: Up to Month 6 (Day 120-180), post second eye implantation
measure: Mean Photopic Without Glare Binocular Distance Contrast Sensitivity
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Mean Photopic With Glare Binocular Distance Contrast Sensitivity
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Mean Mesopic With Glare Binocular Distance Contrast Sensitivity
timeFrame: Month 6 (Day 120-180), post second eye implantation
Secondary outcomes:
measure: Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)
timeFrame: Month 6 (Day 120-180), post second eye implantation
measure: Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID
timeFrame: Month 6 (Day 120-180), post second eye implantation
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Alcon Investigative Site
state: California
city: Mount Dora
country: United States
facility: Alcon Investigative Site
state: Florida
city: Panama City
country: United States
facility: Alcon Investigative Site
state: Florida
city: Poughkeepsie
country: United States
facility: Alcon Investigative Site
state: New York
city: Mount Pleasant
country: United States
facility: Alcon Investigative Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Alcon Investigative Site
state: South Dakota
city: Nashville
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Alcon Investigative Site
state: Texas
city: Hurst
country: United States
facility: Alcon Investigative Site
state: Texas
city: Nacogdoches
country: United States
facility: Alcon Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Alcon Investigative Site
state: Utah
city: Norfolk
country: United States
facility: Alcon Investigative Site
state: Virginia
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References: