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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00732225 | DisCoVisc Comparative Evaluation | PHASE3 | COMPLETED | 173 | — | — | May 1, 2007 | - | Jul 30, 2010 | 1 | United States |
Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.
| Arm | Type | Description |
|---|---|---|
| DisCoVisc | ACTIVE_COMPARATOR | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) |
| DuoVisc | ACTIVE_COMPARATOR | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) |
| BioVisc | ACTIVE_COMPARATOR | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) |
| Healon5 | ACTIVE_COMPARATOR | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) |
| Amvisc Plus | ACTIVE_COMPARATOR | Bausch \& Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Name | Type | Description |
|---|---|---|
| DisCoVisc | DEVICE | DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
| DuoVisc | DEVICE | DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
| BioVisc | DEVICE | BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
| Healon5 | DEVICE | Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
| Amvisc Plus | DEVICE | Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
Inclusion Criteria: * Unilateral operable cataracts Exclusion Criteria: * Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2 * Intraocular Pressure (IOP) \> 21 * History of ocular inflammation * Systemic or ocular diseases affecting corneal endothelium