Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery

FSV6

Status: Enrolling

Conditions: Cataract

Treatments: Device: Cataract Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT04756908

CIP-04

Details and patient eligibility

About

This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.

Full description

This is a prospective, multicenter clinical study comparing the safety and performance of the Opira accommodative IOL, a commercial monofocal IOL, and a commercial multifocal IOL. Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity

Exclusion criteria

• Comorbidities affecting visual acuity, IOP > 22mmHg, congential cataract

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Opira AIOL

Experimental group

Treatment:

Device: Cataract Surgery

Monofocal AIOL

Active Comparator group

Treatment:

Device: Cataract Surgery

Multifocal AIOL

Active Comparator group

Treatment:

Device: Cataract Surgery