Cataract
Conditions
Brief summary
This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).
Interventions
DEVICEModel DIU
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
DEVICEModel DFW
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
DEVICEModel ZCT
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes: 1. Male or female at least 22 years of age 2. Have a cataract in one or both eyes, with planned phacoemulsification and intraocular lens implantation with a toric intraocular lens 3. Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular lens in the study eye(s) 4. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits 5. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.
Exclusion criteria
Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes: 1. Best-corrected distance visual acuity better than 20/40 Snellen (0.3 logMAR) 2. Potential visual acuity estimated to be worse than 20/32 Snellen (0.2 logMAR) 3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs 4. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study 5. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) or unable to dilate to visualize IOL axis (approximately 6.0 mm) 6. Inability to achieve keratometric stability for contact lens wearers (as defined in Section 10.3 Preoperative Procedures) 7. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject 8. Use of systemic or ocular medications that may affect vision 9. Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) 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) 10. Poorly controlled diabetes 11. Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable. 12. Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes 13. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit 14. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotational Stability of IOL | 1 month | The percentage of eyes with rotational stability of the IOL at postoperative 1 month. |
Countries
United States
Participant flow
Pre-assignment details
A total of 37 subjects were consented. Out of 37 subjects, 2 subjects were screen failures and 35 subjects were enrolled and completed the study. Out of 35 subjects, 11 subjects were treated with Test Lens 1 (TECNIS Eyhance Toric II IOL), 13 subjects were treated with Test Lens 2 (TECNIS Synergy Toric II IOL), and 11 subjects were treated with control lens (TECNIS Toric 1-Piece IOL).
Participants by arm
| Arm | Count |
|---|---|
| Test Lens 1 TECNIS Eyhance Toric II IOL | 11 |
| Test Lens 1 TECNIS Eyhance Toric II IOL | 19 |
| Test Lens 2 TECNIS Synergy Toric II IOL | 13 |
| Test Lens 2 TECNIS Synergy Toric II IOL | 22 |
| Control Lens TECNIS Toric 1-Piece IOL | 11 |
| Control Lens TECNIS Toric 1-Piece IOL | 17 |
| Total | 93 |
Baseline characteristics
| Characteristic | Test Lens 1 | Test Lens 2 | Control Lens | Total |
|---|---|---|---|---|
| Age, Customized <60 | 2 Years | 2 Years | 0 Years | 4 Years |
| Age, Customized 60-69 | 2 Years | 7 Years | 3 Years | 12 Years |
| Age, Customized 70-79 | 5 Years | 3 Years | 7 Years | 15 Years |
| Age, Customized >=80 | 2 Years | 1 Years | 1 Years | 4 Years |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 1 Participants | 2 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 10 Participants | 11 Participants | 4 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 8 Participants | 4 Participants | 15 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 7 Participants | 4 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 | 0 / 11 |
Outcome results
Primary
Rotational Stability of IOL
The percentage of eyes with rotational stability of the IOL at postoperative 1 month.
Time frame: 1 month
Population: All eyes with available data at 1 month visit.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Test Lens 1 | Rotational Stability of IOL | 19 Eyes |
| Test Lens 2 | Rotational Stability of IOL | 22 Eyes |
| Control Lens | Rotational Stability of IOL | 16 Eyes |