Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

Lenstec Incorporated390 enrolled

Overview

The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.

The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

390

Conditions

Cataract

Interventions

Lenstec Softec HD IOL implantationDEVICE

surgical removal of cataract and implantation of Softec HD PCIOL

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Cataract requiring cataract extraction * Study IOL to only be implanted in 1 eye * Distance BCVA 20/40 or worse or glare acuity worse than 20/30 * Ability to comply with study follow-up requirements Exclusion Criteria: * Patients with serious corneal disease, previous surgery or serious systemic disease * Ocular condition that could impact vision after cataract surgery * Pregnant or lactating women * Use of ocular or systemic medications that could impact vision

Outcomes

Primary Outcomes

Distance Best Corrected Visual Acuity

Time frame: 1 year

Secondary Outcomes

FDA IOL Grid Adverse Events

Time frame: through 1 year

Data from ClinicalTrials.gov

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