Cataract, Corneal Astigmatism
Conditions
Brief summary
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.
Interventions
DEVICETECNIS® Toric II
Toric Intraocular Lens
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. Minimum 22 years of age; 2. Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned; 3. Pre-existing corneal astigmatism of one diopter or greater; 4. Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D; 5. Potential for postoperative BCDVA of 20/30 Snellen or better; 6. Clear intraocular media other than cataract in each eye; 7. Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits; 8. Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization; 9. Ability to understand and respond to a questionnaire in English.
Exclusion criteria
1. Irregular corneal astigmatism; 2. Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear; 3. Previous corneal or intraocular surgery; 4. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.); 5. Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils); 6. Dilated pupil size of \< 6.0 mm; 7. Recurrent severe anterior or posterior segment inflammation or uveitis; 8. 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; 9. Known ocular or systemic disease that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, \[macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.\]; 10. Use of systemic or ocular medications (e.g., Flomax) that may affect vision including prior, current, or anticipated use during the course of the study that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery); 11. 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; 12. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study. 13. Planned monovision correction (eye designated for near correction)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit | 1 week postoperative | Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method. |
Countries
United States
Participant flow
Pre-assignment details
A total of 125 subjects were enrolled. A total of 202 eyes were implanted with the TECNIS Toric II IOL in at least one eye: 80 subjects were treated bilaterally (77 subjects with study lens on both eyes, 3 subjects with non-study lens on first eye and study lens on second eye) and 45 subjects were treated unilaterally. All implanted subjects were examined through 3-months postoperatively.
Participants by arm
| Arm | Count |
|---|---|
| Tecnis Toric II IOL Study lens | 125 |
| Total | 125 |
Baseline characteristics
| Characteristic | Tecnis Toric II IOL |
|---|---|
| Age, Customized 60-69 years | 47 Participants |
| Age, Customized <60 years | 17 Participants |
| Age, Customized 70-79 years | 53 Participants |
| Age, Customized >+80 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 112 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 125 |
| other Total, other adverse events | 0 / 125 |
| serious Total, serious adverse events | 4 / 125 |
Outcome results
Primary
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit
Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.
Time frame: 1 week postoperative
Population: All Toric II Eyes with Valid Axis Data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tecnis Toric II IOL | Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit | 99.5 Percentage of Eyes |