AcrySof IQ Toric A-Code Post-Market Clinical Study

Alcon

Status: Completed

Conditions: Cataract; Astigmatism

Treatments: Device: AcrySof IQ Toric A-code IOL; Procedure: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT03350503

ILV814-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

125 participants in 1 patient group

Acrysof IQ Toric A-code IOL

Experimental group

Description:

IOL implanted during cataract surgery

Treatment:

Device: AcrySof IQ Toric A-code IOL

Procedure: Cataract surgery