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Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

Primary Purpose

Cataract, Corneal Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TECNIS® TORIC II Intraocular Lens (IOL)
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
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:

  1. Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
  2. Preoperative corneal astigmatism of one diopter or more in the operative eye;
  3. Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
  4. Clear intraocular media other than cataract in each eye;
  5. Ability to understand, read and write English in order to consent to study participation;
  6. Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
  7. Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

  1. Recurrent severe anterior or posterior segment inflammation or uveitis;
  2. Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
  3. Circumstances that would result in damage to the endothelium during implantation;
  4. Suspected ocular microbial infection;
  5. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
  6. Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, [macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.];
  7. Planned monovision correction;
  8. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.

Sites / Locations

  • Empire Eye & Laser Center
  • Jones Eye Clinic
  • Chesapeake Eye Care and Laser Center
  • Eye Doctors of Washington
  • Oakland Ophthalmic Surgery, P.C.
  • Tekwani Vision Center
  • Cincinnati Eye Institute
  • Carolina Cataract & Laser Center
  • Key & Whitman Eye Center
  • Texas Eye and Laser Center
  • Parkhurst NuVision
  • Clarus Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TECNIS® TORIC II Intraocular Lens (IOL)

Arm Description

Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion

Outcomes

Primary Outcome Measures

Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).

Secondary Outcome Measures

Full Information

First Posted
December 23, 2019
Last Updated
October 7, 2021
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04210232
Brief Title
Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
Official Title
Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
September 11, 2020 (Actual)
Study Completion Date
September 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TECNIS® TORIC II Intraocular Lens (IOL)
Arm Type
Experimental
Arm Description
Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion
Intervention Type
Device
Intervention Name(s)
TECNIS® TORIC II Intraocular Lens (IOL)
Intervention Description
Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.
Primary Outcome Measure Information:
Title
Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
Description
Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).
Time Frame
3 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned; Preoperative corneal astigmatism of one diopter or more in the operative eye; Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better; Clear intraocular media other than cataract in each eye; Ability to understand, read and write English in order to consent to study participation; Availability, willingness, sufficient cognitive awareness to comply with examination procedures; Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization. Exclusion Criteria: Recurrent severe anterior or posterior segment inflammation or uveitis; Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; Circumstances that would result in damage to the endothelium during implantation; Suspected ocular microbial infection; Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects; Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, [macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.]; Planned monovision correction; Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Empire Eye & Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Jones Eye Clinic
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Chesapeake Eye Care and Laser Center
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
Oakland Ophthalmic Surgery, P.C.
City
Birmingham
State/Province
Michigan
ZIP/Postal Code
48009
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Carolina Cataract & Laser Center
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
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
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clarus Eye Center
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
IPD Sharing URL
http://yoda.yale.edu

Learn more about this trial

Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

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