Cataracts
Conditions
Brief summary
Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.
Interventions
DEVICETest IOL Model DEN00V
Eligible subjects will be randomized in a 1:1 ratio to receive either the Test IOL Model DEN00V or Control in both eyes for the duration of the study
DEVICEControl IOL Model DCB00
Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model 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
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be considered for enrollment in this study, patient must: * be at least 22 years old * have cataracts in both eyes * sign the written informed consent * be willing and able to comply with examination procedures * understand, read and write English to complete informed consent and questionnaires * be available for study follow-up visits
Exclusion criteria
Patient will not be eligible to take part in the study if: * currently participating in any other clinical study or have participated in a clinical study during the last 30 days * have a certain disease/illness, such as poorly controlled diabetes * have certain ocular conditions, such as uncontrolled pressure in the eye * taking medication that may affect vision * pregnant, plan to become pregnant during the study, or are breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular (First Eyes) Photopic DCIVA at 66 cm | 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 (First Eyes) Depth of Focus | 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. |
| Monocular (First Eyes) Photopic BCDVA at 4m | 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 (First Eyes) Photopic DCVA at 100 cm | 6 months | Monocular photopic Distance Corrected Visual Acuity (DCVA) in logMAR at 100 cm for first eyes. 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 DCB00 IOL (monofocal; control). Enrollment targeted up to 250 subjects at up to 10 sites to achieve \ 200 bilaterally implanted subjects (100 per group) evaluable at 6 months.
Pre-assignment details
Out of 245 enrolled participants a total of 228 participants were randomized in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized <65 years old | 52 Participants |
| Age, Customized >=65 years old | 176 Participants |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 102 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Race Asian | 8 Participants |
| Race (NIH/OMB) Race Black or African American | 15 Participants |
| Race (NIH/OMB) Race More than one race | 0 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Race White | 185 Participants |
| Sex: Female, Male Sex Female | 141 Participants |
| Sex: Female, Male Sex Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 115 | 0 / 113 |
| other Total, other adverse events | 3 / 115 | 3 / 113 |
| serious Total, serious adverse events | 13 / 115 | 8 / 113 |
Outcome results
None listed