Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lenstec Softec HD IOL implantation

Device

surgical removal of cataract and implantation of Softec HD PCIOL

Other names: Softec HD PCIOL, Softec HD Posterior Chamber IOL, Softec HD Posterior Chamber Intraocular Lens

Primary outcomes

Distance Best Corrected Visual Acuity

Time frame: 1 year

Secondary outcomes

FDA IOL Grid Adverse Events

Time frame: through 1 year

Sponsors and collaborators

Lead sponsor

Lenstec Incorporated

Industry

Registry information

Official study title

Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2010
First posted: Aug 21, 2009
Registry last updated: Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed