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Clinical Investigation of the Next Generation Intraocular Lens

CompletedNA

Sponsor: Johnson & Johnson Surgical Vision, Inc.

Conditions: Cataract

Interventions: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL, Control Monofocal Intraocular Lens: TECNIS Monofocal IOL

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (10)

Torrance, California, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
Sioux City, Iowa, United States
Cincinnati, Ohio, United States
Kingston, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States