Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/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
- 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
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Empire Eye & Laser Center | Bakersfield | California | United States | 93309 |
| 2 | Jones Eye Clinic | Sioux City | Iowa | United States | 51104 |
| 3 | Chesapeake Eye Care and Laser Center | Annapolis | Maryland | United States | 21401 |
| 4 | Eye Doctors of Washington | Chevy Chase | Maryland | United States | 20815 |
| 5 | Oakland Ophthalmic Surgery, P.C. | Birmingham | Michigan | United States | 48009 |
| 6 | Tekwani Vision Center | Saint Louis | Missouri | United States | 63109 |
| 7 | Cincinnati Eye Institute | Cincinnati | Ohio | United States | 45242 |
| 8 | Carolina Cataract & Laser Center | Ladson | South Carolina | United States | 29456 |
| 9 | Key & Whitman Eye Center | Dallas | Texas | United States | 75243 |
| 10 | Texas Eye and Laser Center | Hurst | Texas | United States | 76054 |
| 11 | Parkhurst NuVision | San Antonio | Texas | United States | 78229 |
| 12 | Clarus Eye Center | Lacey | Washington | United States | 98503 |
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.- NXGT-201-TTL2
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 87 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 Title | TECNIS Toric II |
|---|---|
| Arm/Group Description | Study Lens |
| Period Title: Overall Study | |
| STARTED | 54 |
| COMPLETED | 54 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | TECNIS Toric II |
|---|---|
| Arm/Group Description | Study Lens |
| Overall Participants | 54 |
| 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
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Toric II Eyes |
| Arm/Group Title | TECNIS Toric II |
|---|---|
| Arm/Group Description | Study Lens |
| Measure Participants | 53 |
| Measure Eyes | 85 |
| Very Satisfied/Satisfied |
100
|
| Undecided/Dissatisfied/Very Dissatisfied |
0
|
Adverse Events
| Time Frame | 3 months postoperative | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | TECNIS Toric II | |
| Arm/Group Description | Study Lens | |
All Cause Mortality |
||
| TECNIS Toric II | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/54 (0%) | |
Serious Adverse Events |
||
| TECNIS Toric II | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/54 (11.1%) | |
| Cardiac disorders | ||
| Hospitalization due to heart attack | 2/54 (3.7%) | 2 |
| Eye disorders | ||
| Cystoid Macular Edema | 1/54 (1.9%) | 1 |
| Gastrointestinal disorders | ||
| Hospitalization due to bleeding varices | 1/54 (1.9%) | 1 |
| Hospitalization due to vomiting of blood | 1/54 (1.9%) | 1 |
| Renal and urinary disorders | ||
| Hospitalization | 1/54 (1.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Hospitalization due to pneumonia | 1/54 (1.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| TECNIS Toric II | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/54 (0%) | |
Limitations/Caveats
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/Title | Eugenia K. Thomas |
|---|---|
| Organization | Johnson & Johnson Surgical Vision |
| Phone | +1 657 2903260 |
| EThoma39@its.jnj.com |
- NXGT-201-TTL2