Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.

Bausch + Lomb

Status: Terminated

Conditions: Cataract

Treatments: Device: Akreos MI Five-O

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804726

580

Details and patient eligibility

About

The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.

Enrollment: 10 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have a clinically documented diagnosis of age-related cataract.
• Subjects must have clear intraocular media other than cataract.
• Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

Exclusion criteria

• Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
• Subjects with diagnosis of degenerative visual disorder.
• Subjects who have any inflammation or edema (swelling) of the cornea.
• Subjects with immunodeficiency disorders.
• Subjects who have had previous intraocular surgery in the study eye.
• Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
• Subjects with chronic use of systemic steroids or immunosuppressive medications.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Akreos MI Five-O

Experimental group

Description:

Accommodating intraocular lens

Treatment:

Device: Akreos MI Five-O