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

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04210232
Collaborator
(none)
54
Enrollment
12
Locations
1
Arm
7.9
Actual Duration (Months)
4.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: TECNIS® TORIC II Intraocular Lens (IOL)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
Actual Study Start Date :
Jan 14, 2020
Actual Primary Completion Date :
Sep 11, 2020
Actual Study Completion Date :
Sep 11, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: TECNIS® TORIC II Intraocular Lens (IOL)

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

Device: TECNIS® TORIC II Intraocular Lens (IOL)
Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.

Outcome Measures

Primary Outcome Measures

  1. Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II [3 months postoperative]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
2Jones Eye ClinicSioux CityIowaUnited States51104
3Chesapeake Eye Care and Laser CenterAnnapolisMarylandUnited States21401
4Eye Doctors of WashingtonChevy ChaseMarylandUnited States20815
5Oakland Ophthalmic Surgery, P.C.BirminghamMichiganUnited States48009
6Tekwani Vision CenterSaint LouisMissouriUnited States63109
7Cincinnati Eye InstituteCincinnatiOhioUnited States45242
8Carolina Cataract & Laser CenterLadsonSouth CarolinaUnited States29456
9Key & Whitman Eye CenterDallasTexasUnited States75243
10Texas Eye and Laser CenterHurstTexasUnited States76054
11Parkhurst NuVisionSan AntonioTexasUnited States78229
12Clarus Eye CenterLaceyWashingtonUnited States98503

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04210232
Other Study ID Numbers:
  • NXGT-201-TTL2
First Posted:
Dec 24, 2019
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail87 subjects signed informed consent in the study. 33 were screen failures and 54 subjects were treated/implanted across 8 clinical sites in the US. Of the 54 subjects treated, 32 subjects were treated bilaterally, and 22 subjects were treated unilaterally.
Arm/Group TitleTECNIS Toric II
Arm/Group DescriptionStudy Lens
Period Title: Overall Study
STARTED54
COMPLETED54
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleTECNIS Toric II
Arm/Group DescriptionStudy Lens
Overall Participants54
Age, Customized (Number) [Number]
<60 years
3
5.6%
60-69 years
19
35.2%
70-79 years
25
46.3%
>=80 years
7
13%
Sex: Female, Male (Count of Participants)
Female
29
53.7%
Male
25
46.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
3.7%
Not Hispanic or Latino
52
96.3%
Unknown or Not Reported
0
0%
Race/Ethnicity, Customized (Number) [Number]
Asian
1
1.9%
African American
2
3.7%
Native hawaiian/Pacific islander
0
0%
Caucasian
51
94.4%
Other
0
0%
Not Reported
0
0%

Outcome Measures

1. Primary Outcome
TitleOverall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
DescriptionPercent 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 Frame3 months postoperative

Outcome Measure Data

Analysis Population Description
All Toric II Eyes
Arm/Group TitleTECNIS Toric II
Arm/Group DescriptionStudy Lens
Measure Participants53
Measure Eyes85
Very Satisfied/Satisfied
100
Undecided/Dissatisfied/Very Dissatisfied
0

Adverse Events

Time Frame3 months postoperative
Adverse Event Reporting Description
Arm/Group TitleTECNIS Toric II
Arm/Group DescriptionStudy Lens
All Cause Mortality
TECNIS Toric II
Affected / at Risk (%)# Events
Total0/54 (0%)
Serious Adverse Events
TECNIS Toric II
Affected / at Risk (%)# Events
Total6/54 (11.1%)
Cardiac disorders
Hospitalization due to heart attack2/54 (3.7%) 2
Eye disorders
Cystoid Macular Edema1/54 (1.9%) 1
Gastrointestinal disorders
Hospitalization due to bleeding varices1/54 (1.9%) 1
Hospitalization due to vomiting of blood1/54 (1.9%) 1
Renal and urinary disorders
Hospitalization1/54 (1.9%) 1
Respiratory, thoracic and mediastinal disorders
Hospitalization due to pneumonia1/54 (1.9%) 1
Other (Not Including Serious) Adverse Events
TECNIS Toric II
Affected / at Risk (%)# Events
Total0/54 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.

Results Point of Contact

Name/TitleEugenia K. Thomas
OrganizationJohnson & Johnson Surgical Vision
Phone+1 657 2903260
EmailEThoma39@its.jnj.com
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04210232
Other Study ID Numbers:
  • NXGT-201-TTL2
First Posted:
Dec 24, 2019
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021