AcrySof IQ Toric A-Code Post-Market Clinical Study

Not Applicable

Completed

• Conditions: Cataract; Astigmatism
• Interventions: Device: AcrySof IQ Toric A-code IOL; Procedure: Cataract surgery

• Registration Number: NCT03350503
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.

Detailed Description

Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.

Study Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-22
• Study Start: 2018-01-30
• Primary Completion: 2019-05-23
• Results First Submitted: 2020-04-21
• Results First Submitted QC: 2020-05-01
• Results First Posted: 2020-05-12
• Study Completion: 2021-12-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acrysof IQ Toric A-code IOL	AcrySof IQ Toric A-code IOL	IOL implanted during cataract surgery
Acrysof IQ Toric A-code IOL	Cataract surgery	IOL implanted during cataract surgery

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)	Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)	IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was 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. No confirmatory hypothesis testing was conducted.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇯🇵 Saga, Saga Prefecture, Japan