Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: AcrySof Monofocal IOL; Device: AcrySof IQ PanOptix Multifocal IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03280108

ILH297-C001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Multifocal IOL

Experimental group

Description:

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).

Treatment:

Device: AcrySof IQ PanOptix Multifocal IOL

Monofocal IOL

Active Comparator group

Description:

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).

Treatment:

Device: AcrySof Monofocal IOL