Clinical trial NCT03111550: Clinical Investigation of the Next-Generation Intraocular Lens
Official title: Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2017-04-13
Enrollment: 242
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL.

The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.


Eligibility criteria: Inclusion Criteria:

* Bilateral cataracts
* Potential for postoperative BCDVA of 20/30 Snellen or better
* Corneal astigmatism of 1.00 D or less in both eyes
* Normal corneal topography
* Clear intraocular media other than cataract in each eye
* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

Exclusion Criteria:

* Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)
* 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
* Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
* Inability to achieve keratometric stability for contact lens wearers
* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
* Subjects with diagnosed degenerative visual disorders
* 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 of tamsulosin or silodosin
* Poorly-controlled diabetes
* Acute, chronic, or uncontrolled systemic or ocular disease or illness
* Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or 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 45 days prior to preoperative visit in any other clinical trial
* Desire for monovision correction

Primary outcomes:
measure: Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
timeFrame: 1 month postoperative
measure: Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
timeFrame: 6 months postoperative
measure: Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye and Laser Center
state: California
city: Beverly Hills
country: United States
facility: Assil Eye Institute
state: California
city: Sioux City
country: United States
facility: Jones Eye Care
state: Iowa
city: Annapolis
country: United States
facility: Chesapeake Eye Care and Laser
state: Maryland
city: Chevy Chase
country: United States
facility: Eye Doctors of Washington
state: Maryland
city: Saint Louis
country: United States
facility: Ophthalmology Consultants LTD
state: Missouri
city: Cranberry Township
country: United States
facility: Scott and Christie and Associates,PC
state: Pennsylvania
city: Ladson
country: United States
facility: Carolina Cataract and Laser Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Goodlettsville
country: United States
facility: Loden Vision Centers
state: Tennessee
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Hurst
country: United States
facility: Texas Eye and Laser Center
state: Texas
Study officials:
affiliation: Abbott Medical Optics
name: Devi Priya Janakiraman, OD,FAAO
role: STUDY_DIRECTOR
References: