Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) Clinical Investigation

Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL)Clinical Investigation

The purpose of the following clinical protocol is to evaluate the safety and effectiveness of the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol inclusion/exclusion criteria.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Experimental TetraFlex Study IOL; Device: posterior chamber IOL implantation

Detailed Description

The Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL) is an ultraviolet absorbing optical implant designed for the replacement of the human crystalline lens following phacoemulsification cataract removal. The TetraFlex Accommodating Posterior Chamber IOL is designed for 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 TetraFlex Accommodating Posterior Chamber IOL is to provide enhanced distance and near vision with an increased independence from corrective lens wear.

• Study Type: Interventional
• Enrollment (Actual): 470
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female
• Any race
• Patients age at time of surgery to be 18 years or older.
• Presence of bilateral cataract requiring cataract extraction. If only one eye is being implanted with the study lens, the other eye may have had cataract extraction with IOL implantation.
• Clear intraocular media other than cataract.
• Patients with BSCVA < 20/40 or cataract with glare acuity worse than 20/30
• Corneal Astigmatism less than 1 Diopter.
• Good Visual Potential: Best corrected visual acuity (BCVA) projected by PAM or Pinhole 20/25 or better if other pathology is suspected.
• Patient is able and willing to comply with follow-up.
• Able to provide written informed consent.

Exclusion Criteria:

• Patients who are monocular.
• Presence of an ocular infection.
• Greater than or equal to 1 Diopter of pre-operative corneal astigmatism.
• Patients who are on anti-psychotic and antidepressant medication that could potentially effect accommodation
• Patients who chronically take any medication that may affect accommodation, including first generation antihistamines, and anticholinergic agents.
• Previous intraocular surgery in either eye.
• Previous serious corneal disease.
• Diagnosis of any of the following ocular conditions: active scleral disease, glaucoma, retinal disease potentially affecting central vision, macular disease or uveitis, severe dry eyes and dysthyroid eye disease
• Subjects who may be expected to require retinal laser treatment.
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse).
• Patients requiring administration of topical ophthalmic medications other than the study medications. Use of systemic corticosteroids or anti-metabolites or other medications that could affect wound healing is specifically contraindicated.
• Allergy to anesthetics or other postoperative medications.
• Presence of any uncontrolled systemic disease (e.g. diabetes, hypertension, cardiovascular disease).
• Pregnant or lactating women
• Persons who, in the determination of the investigator, are not competent to understand the procedure, the actions asked of them as research subjects, or capable of completing the patient satisfaction questionnaire.
• Participation in a previous clinical trial within the 30 days prior to the start of the study.
• Persons who may not be able to complete the requirements of returning to the investigator's clinic over the period of the study, or who may be difficult to locate or contact on short notice. This does not preclude vacations or travel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenstec Tetraflex IOL implantation; patients in Study arm received TetraFlex Lens	Device: Experimental TetraFlex Study IOL; TetraFlex IOL implanted
Active Comparator: Control IOL; commercially approved PCIOL implanted	Device: posterior chamber IOL implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary efficacy outcome is the assessment of the % of eyes obtaining 20/40 or better distance best corrected visual acuity.	1 year
The primary safety outcome is the incidence/severity of adverse events and complications.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient's functional reading ability, and other distance, near and intermediate vision testing including subjective patient survey outcomes on dependence on corrective eyewear and patient symptoms.	1 year

Collaborators and Investigators

• Sponsor: Lenstec Incorporated
• Investigators: Study Director: Donald R Sanders, MD, PhD, Center for Clinical Research

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 31, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (Estimate): September 1, 2009

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: posterior chamber intraocular lens; PCIOL; IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IDE G050048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No