AcrySof IQ Toric Post-Market Clinical Study

Not Applicable

• Conditions: Cataract

• Registration Number: JPRN-jRCTs072180020
• Lead Sponsor: Miyata Kazunori

Brief Summary

Only one subject had an absolute IOL rotation from Visit 00 (During surgery) < 10 degrees at Visit 4 (Day 120-180). The results of percentages of each category (< 10 degrees, < 20 degrees, < 30 degrees) were greater than performance targets in ISO (EN ISO 11979-7:2014). 68 ocular adverse events were reported in 49 eyes (20.2%). In ocular adverse events, diseases or the like were occurred in 2 eyes and SAEs were occurred in 2 eyes. The study discontinuation due to ocular adverse event was not reported.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-21
• Study Completion: 2021-12-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 121

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified