Clinical trial NCT02203721: Clinical Investigation of a New Intraocular Lens
Official title: Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 324
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.


Eligibility criteria: Inclusion Criteria:

* Minimum 22 years of age
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
* Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
* Potential for postoperative BCDVA of 20/30 Snellen or better
* Corneal astigmatism
* Clear intraocular media, other than cataract
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent and HIPAA authorization
* Ability to understand and respond to a questionnaire in English or Spanish

Exclusion Criteria:

* Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D
* Pupil abnormalities
* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
* Prior corneal refractive or intraocular surgery
* Corneal abnormalities
* Inability to achieve keratometric stability for contact lens wearers
* Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
* Use of systemic or ocular medications that may affect vision
* Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject
* Inability to focus or fixate for prolonged periods of time
* Poorly-controlled diabetes
* Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study.
* May be expected to require retinal laser treatment or other surgical intervention during the course of the study
* 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 30 days prior to preoperative visit in any other clinical trial
* Desire for monovision correction

Primary outcomes:
measure: Distance Corrected Intermediate Visual Acuity
timeFrame: At 6 months
measure: Uncorrected Intermediate Visual Acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Boozman-Hof Regional Eye Clinic
state: Arkansas
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Boynton Beach
country: United States
facility: Katzen Eye Care & Laser Center
state: Florida
city: Cape Coral
country: United States
facility: Cape Coral Eye Center
state: Florida
city: Rock Island
country: United States
facility: Virdi Eye Clinic & Laser Vision Center
state: Illinois
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: Chevy Chase
country: United States
facility: Eye Doctors of Washington
state: Maryland
city: Rockville Center
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Allenwood
country: United States
facility: The Eye Center of Central PA
state: Pennsylvania
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Loden Vision Center
state: Tennessee
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: Hurst
country: United States
facility: Texas Eye and Laser Center
state: Texas
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
Study officials:
References:
citation: Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. J Cataract Refract Surg. 2022 Mar 1;48(3):288-297. doi: 10.1097/j.jcrs.0000000000000747.