Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Completed · Not applicable
Conditions studied: Cataract, Corneal Astigmatism
In brief
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
Key facts
- Study ID
- NCT03949335
- Run by
- Johnson & Johnson Surgical Vision, Inc.
- People needed
- 272
- Starts
- 2019-07-31
- Expected to finish
- 2020-06-18
- Last updated by the study team
- 2021-08-27
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Empire Eye & Laser Center — Bakersfield, California, United States
- Wolstan & Goldberg Eye Associates — Torrance, California, 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
- Cincinnati Eye Institute — Blue Ash, Ohio, United States
- Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
- Carolina EyeCare Physicians — Mt. Pleasant, South Carolina, United States
- Vance Thompson Vision — Sioux Falls, South Dakota, United States
- Key-Whitman Eye Center — Dallas, Texas, United States
- Berkeley Eye Institute — Houston, Texas, United States
- Texas Eye and Laser Center — Hurst, Texas, United States
- Lehmann Eye Center — Nacogdoches, Texas, United States
- Focal Point Vision — San Antonio, Texas, United States
- Clarus Eye Centre — Lacey, Washington, United States
Full record on ClinicalTrials.gov
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