Cataracts
Conditions
Brief summary
Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.
Interventions
DEVICEinvestigational IOL Model DEN00V
Eligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study.
DEVICEcontrol IOL Model ZCB00/DCB00
Eligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study.
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
1. Minimum 22 years of age; 2. Bilateral cataracts for which posterior chamber IOL implantation has been planned; 3. Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source; 4. Potential for postoperative BCDVA of 20/30 Snellen or better; 5. Corneal astigmatism: 1. Normal corneal topography; 2. ≤ 1.0 D of preoperative keratometric astigmatism; 6. Clear intraocular media other than cataract; 7. Availability, ability, willingness and sufficient cognitive awareness to comply with examination procedures; 8. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries; 9. Ability to understand and respond to a questionnaire in English.
Exclusion criteria
1. Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D; 2. Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils); 3. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.); 4. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.); 5. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study; 6. Irregular corneal astigmatism; 7. Inability to achieve keratometric stability for contact lens wearers (as defined in preoperative procedures); 8. History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs; 9. Recent ocular trauma that is not resolved/stable or may affect visual outcomes or increase risk to the subject; 10. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study; 11. 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; 12. Use of systemic or ocular medications that may affect vision; 13. Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery); 14. Poorly controlled diabetes; 15. 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 outcomes 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; 16. Known ocular disease or pathology that, in the opinion of the investigator: 1. may affect visual acuity; 2. may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.); 3. may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.); 17. Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes; 18. Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial; 19. Desire for monovision correction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular DCIVA at 66cm for First Eyes | 6 Months | Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye. |
| Monocular BCDVA at 4 Meters for First Eyes | 6 Months | Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye. |
| Monocular Depth of Focus for First Eyes | 6 Months | Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye. |
Countries
United States
Contacts
STUDY_DIRECTORJohnson & Johnson Surgical Vision, Inc. Clinical Trial
Johnson & Johnson Surgical Vision, Inc.
Participant flow
Recruitment details
Prospective, multicenter, bilateral, interventional, controlled, masked, randomized, clinical investigation of the DEN00V IOL (EDF; test) and the ZCB00/DCB00 IOL (monofocal; control). Enrollment targeted up to 250 participants at up to 10 sites to achieve \ 200 bilaterally implanted participants (100 per group) evaluable at 6 months.
Pre-assignment details
Out of 243 enrolled participants a total of 202 participants were randomized in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 60-69 years old | 78 Participants |
| Age, Customized <60 years old | 15 Participants |
| Age, Customized 70-79 years old | 95 Participants |
| Age, Customized >=80 years old | 14 Participants |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 90 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Race Asian | 10 Participants |
| Race (NIH/OMB) Race Black or African American | 11 Participants |
| Race (NIH/OMB) Race More than one race | 1 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race White | 167 Participants |
| Sex: Female, Male Sex Female | 127 Participants |
| Sex: Female, Male Sex Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 99 | 0 / 99 |
| other Total, other adverse events | 0 / 99 | 0 / 99 |
| serious Total, serious adverse events | 9 / 99 | 7 / 99 |
Outcome results
None listed