Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

Not Applicable

Completed

Conditions: Cataract

Interventions: Device: AcrySof® IQ PanOptix™ IOL

Registration Number: NCT03090256

Lead Sponsor: Alcon Research

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PanOptix IOL	AcrySof® IQ PanOptix™ IOL	AcrySof® IQ PanOptix™ IOL, bilateral implantation

Primary Outcome Measures

Name	Time	Method
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation	VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation	Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation	VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.