Cataract, Corneal Astigmatism
Conditions
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.
Interventions
DEVICETECNIS® TORIC II Intraocular Lens (IOL)
Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| TECNIS Toric II Study Lens | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | TECNIS Toric II |
|---|---|
| Age, Customized 60-69 years | 19 Participants |
| Age, Customized <60 years | 3 Participants |
| Age, Customized 70-79 years | 25 Participants |
| Age, Customized >=80 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized African American | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 51 Participants |
| Race/Ethnicity, Customized Native hawaiian/Pacific islander | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 6 / 54 |
Outcome results
Primary
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).
Time frame: 3 months postoperative
Population: All Toric II Eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TECNIS Toric II | Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II | Very Satisfied/Satisfied | 100 Percentage of eyes |
| TECNIS Toric II | Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II | Undecided/Dissatisfied/Very Dissatisfied | 0 Percentage of eyes |