Clinical Investigation of the Next-Generation Intraocular Lens

Cataract Clinical Trial

Official title:

Clinical Investigation of the TECNIS Next-Generation Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111550
• Other study ID #: EDOF-121-NGPC
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: August 2020
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
Intraocular lens replaces the natural lens removed during cataract surgery.
• Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
Intraocular lens replaces the natural lens removed during cataract surgery.
• TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Intraocular lens replaces the natural lens removed during cataract surgery.

Locations

Country	Name	City	State
United States	Chesapeake Eye Care and Laser	Annapolis	Maryland
United States	Empire Eye and Laser Center	Bakersfield	California
United States	Assil Eye Institute	Beverly Hills	California
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	Scott and Christie and Associates,PC	Cranberry Township	Pennsylvania
United States	Key-Whitman Eye Center	Dallas	Texas
United States	Loden Vision Centers	Goodlettsville	Tennessee
United States	Texas Eye and Laser Center	Hurst	Texas
United States	Carolina Cataract and Laser Center	Ladson	South Carolina
United States	Ophthalmology Consultants LTD	Saint Louis	Missouri
United States	Jones Eye Care	Sioux City	Iowa
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm	The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative	1 month postoperative
Primary	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)	Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution.; ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).; ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.; SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US).; Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.	6 months postoperative
Primary	Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)	Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution.; Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.	6 months postoperative