Clinical Investigation of the Next Generation Intraocular Lens

Completed · Not applicable

Conditions studied: Cataract

In brief

An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

Key facts

Study ID

NCT03500198

Run by

Johnson & Johnson Surgical Vision, Inc.

People needed

247

Starts

2018-06-28

Expected to finish

2019-06-05

Last updated by the study team

2020-06-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Minimum 22 years of age
• Bilateral cataracts for which posterior chamber IOL implantation has been planned
• Corneal astigmatism:
• Normal corneal topography
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• Ability to understand and respond to a questionnaire in English

You may not qualify if…

• Irregular corneal astigmatism
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
• Poorly-controlled diabetes
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Where it is running

• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• The Eye Associates of Manatee, LLP — Bradenton, Florida, United States
• Levenson Eye Associates, Inc. — Jacksonville, Florida, United States
• Jones Eye Clinic — Sioux City, Iowa, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• Eye Care Specialists — Kingston, Pennsylvania, United States
• Vance Thompson Vision Clinic, Prof LLC — Sioux Falls, South Dakota, United States
• Key-Whitman Eye Center — Dallas, Texas, United States
• Berkeley Eye Institute, P.A. — Houston, Texas, United States
• Slade & Baker Vision — Houston, Texas, United States

Full record on ClinicalTrials.gov

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