cataract
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Diagnosis of cataracts with planned cataract removal by phacoemulsification -Calculated lens power within the available range -Able to sign informed consent and complete all study visits -Other protocol-defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: -Eye conditions as specified in the protocol -Uncontrolled glaucoma -Pregnancy, current or planned -Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with absolute value of IOL rotation of less than 10 degrees at Visit 4 from Visit 00 IOL rotation is defined as the IOL axis difference between study visits. A photograph of the eye will be taken, and IOL rotation will be calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)] 2. Percentage of patients with absolute value of IOL rotation of less than 20 degrees at Visit 4 from Visit 00 [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)] 3. Percentage of patients with absolute value of IOL rotation of less than 30 degrees at Visit 4 from Visit 00 [Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)] | — |
Countries
Japan
Contacts
Alcon Japan Ltd. Clinical Development