AcrySof IQ Toric Post-Market Clinical Study

JRCT ID: jRCTs072180020

Registered date:21/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 30/01/2018
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Device: AcrySof IQ Toric A-code IOL
Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient

Outcome(s)

Primary Outcome

- 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)
- 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)
- 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)

• Secondary Outcome: N/A

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

-Eye conditions as specified in the protocol
-Uncontrolled glaucoma
-Pregnancy, current or planned
-Other protocol-defined exclusion criteria may apply

Related Information

• Primary Sponsor: Miyata Kazunori
• Source(s) of Monetary Support: Alcon Japan Ltd.
• Secondary ID(s): NCT03350503,UMIN000030848