Clinical trial NCT03500198: Clinical Investigation of the Next Generation Intraocular Lens
Official title: Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 247
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
timeFrame: 6 months (postoperative)
measure: Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
timeFrame: 6 months (postoperative)
Secondary outcomes:
measure: Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
timeFrame: 6 months (postoperative)
measure: Overall Spectacle Wear
timeFrame: 6 months (postoperative)
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Bradenton
country: United States
facility: The Eye Associates of Manatee, LLP
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates, Inc.
state: Florida
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision Clinic, Prof LLC
state: South Dakota
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Houston
country: United States
facility: Berkeley Eye Institute, P.A.
state: Texas
city: Houston
country: United States
facility: Slade & Baker Vision
state: Texas
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Devi Priya Janakiraman, OD, FAAO
role: STUDY_DIRECTOR
References: