Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test IOL | Experimental | DEN00V |
|
| Control IOL | Active Comparator | DCB00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test IOL Model DEN00V | Device | Eligible subjects will be randomized in a 1:1 ratio to receive the Test IOL Model DEN00V in both eyes for the duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular photopic DCIVA (first eyes) at 66 cm | Mean DCIVA (logMAR) in test lens group is statistically significantly better (smaller) than in the control lens group | 6 months |
| Monocular Depth of Focus | Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero) for first eyes at 6 months | 6 months |
| Monocular Photopic BCDVA at 4m | Monocular photopic BCDVA at 4 meters for first eyes at 6 months | 6 months |
| Monocular Photopic DCVA at 100 cm | Monocular photopic DCVA at 100 cm for first eyes at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular photopic DCNVA at 40 cm (first eyes) | Mean DCNVA (logMAR) in the test lens group is statistically significantly better (smaller) than in the control lens group | 6 months |
Not provided
INCLUSION CRITERIA
To be considered for enrollment in this study, patient must:
Patient will not be eligible to take part in the study if:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision, Inc. Clinical Trial | Johnson & Johnson Surgical Vision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States | ||
| Levenson Eye Associates |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 16, 2026 | May 6, 2026 | 17 | ||
| May 28, 2026 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control IOL Model DCB00 | Device | 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 |
|
| Jacksonville |
| Florida |
| 32204 |
| United States |
| Jones Eye Center | Sioux City | Iowa | 51104 | United States |
| OCLI Vision | Garden City | New York | 11530 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Berkeley Eye Institute | Houston | Texas | 77027 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| Jun 23, 2026 |
| 18 |