Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01098812 | Clinical Evaluation of a 1-Piece Intraocular Lens | PHASE3 | COMPLETED | 269 | — | — | Mar 1, 2010 | Oct 1, 2011 | Feb 4, 2025 | - | — |
Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.
| Arm | Type | Description |
|---|---|---|
| Control IOL | ACTIVE_COMPARATOR | Approved Intraocular control lens |
| Toric IOL | EXPERIMENTAL | Investigational Toric IOL |
| Higher Cylinder Toric IOL | EXPERIMENTAL | Investigational Toric IOLs with higher cylinder powers. |
| Name | Type | Description |
|---|---|---|
| Tecnis ZCB00 IOL (control) | DEVICE | Tecnis 1-piece acrylic IOL |
| Toric Intraocular lens | DEVICE | Toric acrylic intraocular lens with various cylinder powers |
Inclusion Criteria: * Minimum 18 years of age * Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes * Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye * BCDV...