Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Enrollment
- 247
- Locations
- 10
- Primary Endpoint
- Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.
Investigators
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
Outcomes
Primary Outcomes
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
Time Frame: 6 months (postoperative)
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Time Frame: 6 months (postoperative)
Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.
Secondary Outcomes
- Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm(6 months (postoperative))
- Overall Spectacle Wear(6 months (postoperative))