Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

Alcon

Status

Completed

Conditions

Cataract

Treatments

Device: AcrySof® IQ PanOptix™ IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT03090256

ILH297-C003

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Full description

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Enrollment

76 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able to comprehend and sign a statement of informed consent;
Willing and able to complete all required postoperative visits;
Cataracts in both eyes with planned cataract removal by phacoemulsification;
Calculated lens power within the available range;
Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
Able to undergo second eye surgery within 30 days of the first eye surgery.

Exclusion criteria

Significant irregular corneal aberration as demonstrated by corneal topography;
Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
Previous refractive surgery;
Diabetic retinopathy
Other eye conditions as specified in the protocol
Pregnant.