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Clinical Investigation of the Next-Generation Intraocular Lens

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Empire Eye and Laser Center
  • Assil Eye Institute
  • Jones Eye Care
  • Chesapeake Eye Care and Laser
  • Eye Doctors of Washington
  • Ophthalmology Consultants LTD
  • Scott and Christie and Associates,PC
  • Carolina Cataract and Laser Center
  • Vance Thompson Vision
  • Loden Vision Centers
  • Key-Whitman Eye Center
  • Texas Eye and Laser Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Investigational Lens Device #1

Investigational Lens Device #2

Control Device

Arm Description

Investigational Intraocular Lens Device #1: Tecnis Model ZHR00

Investigational Intraocular Lens Device #2: Tecnis Model ZQR00

Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2017
Last Updated
August 7, 2020
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT03111550
Brief Title
Clinical Investigation of the Next-Generation Intraocular Lens
Official Title
Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
subject/evaluator-masked
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Lens Device #1
Arm Type
Other
Arm Description
Investigational Intraocular Lens Device #1: Tecnis Model ZHR00
Arm Title
Investigational Lens Device #2
Arm Type
Other
Arm Description
Investigational Intraocular Lens Device #2: Tecnis Model ZQR00
Arm Title
Control Device
Arm Type
Other
Arm Description
Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Intervention Type
Device
Intervention Name(s)
Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
Intervention Description
Intraocular lens replaces the natural lens removed during cataract surgery.
Intervention Type
Device
Intervention Name(s)
Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
Intervention Description
Intraocular lens replaces the natural lens removed during cataract surgery.
Intervention Type
Device
Intervention Name(s)
TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Intervention Description
Intraocular lens replaces the natural lens removed during cataract surgery.
Primary Outcome Measure Information:
Title
Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Description
The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative
Time Frame
1 month postoperative
Title
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)
Description
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.
Time Frame
6 months postoperative
Title
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
Description
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.
Time Frame
6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devi Priya Janakiraman, OD,FAAO
Organizational Affiliation
Abbott Medical Optics
Official's Role
Study Director
Facility Information:
Facility Name
Empire Eye and Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Assil Eye Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Jones Eye Care
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Chesapeake Eye Care and Laser
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Eye Doctors of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Ophthalmology Consultants LTD
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Scott and Christie and Associates,PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Carolina Cataract and Laser Center
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Loden Vision Centers
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Texas Eye and Laser Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Investigation of the Next-Generation Intraocular Lens

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