Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

Not Applicable

Completed

Brief Summary: This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization.

After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule

Recruitment & Eligibility

Inclusion Criteria

be at least 22 years old
have cataracts in both eyes
sign the written informed consent
be willing and able to comply with examination procedures
understand, read and write English to complete informed consent and questionnaires
be available for study follow-up visits

Exclusion Criteria

currently participating in any other clinical study or have participated in a clinical study during the last 60 days
have a certain disease/illness such as poorly-controlled diabetes
have certain ocular conditions such as uncontrolled glaucoma
Is taking medication that may affect vision
Subject is pregnant, plan to become pregnant during the study, or is breastfeeding

Arm && Interventions

Group	Intervention	Description
Investigational	IOL Model ZFR00V	Bilateral implantation with investigational IOL Model ZFR00V
Control	IOL Model ZCB00	Bilateral implantation with control IOL Model ZCB00

Primary Outcome Measures

Name	Time	Method
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm	6 months (postoperative)	mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months

Secondary Outcome Measures

Name	Time	Method
Monocular Distance-Corrected Defocus Curve	6 months postoperative	Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population
Spectacle Wear	6 months postoperative	Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.
Monocular Distance-Corrected Near Visual Acuity at 33 cm	6 months postoperative	mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months
Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm	6 months (postoperative)	mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population
Monocular Photopic Best-Corrected Distance Visual Acuity	6 months postoperative	mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.

Locations (15): Key-Whitman Eye Center
🇺🇸
Dallas, Texas, United States
Empire Eye & Laser Center
🇺🇸
Bakersfield, California, United States
Wolstan & Goldberg Eye Associates
🇺🇸
Torrance, California, United States
Cincinnati Eye Institute
🇺🇸
Blue Ash, Ohio, United States
Katzen Eye Care & Laser Center
🇺🇸
West Palm Beach, Florida, United States
Jones Eye Clinic
🇺🇸
Sioux City, Iowa, United States
Chesapeake Eye Care & Laser Center
🇺🇸
Annapolis, Maryland, United States
Scott & Christie and Associates, PC
🇺🇸
Cranberry Township, Pennsylvania, United States
Vance Thompson Vision
🇺🇸
Sioux Falls, South Dakota, United States
Berkeley Eye Institute
🇺🇸
Houston, Texas, United States
Texas Eye and Laser Center
🇺🇸
Hurst, Texas, United States
Clarus Eye Centre
🇺🇸
Lacey, Washington, United States
Lehmann Eye Center
🇺🇸
Nacogdoches, Texas, United States
Carolina EyeCare Physicians
🇺🇸
Mount Pleasant, South Carolina, United States
Focal Point Vision
🇺🇸
San Antonio, Texas, United States