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

NCT ID: NCT00969371

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-06-30

Brief Summary

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.

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.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lenstec Tetraflex IOL implantation

patients in Study arm received TetraFlex Lens

Group Type: EXPERIMENTAL

Experimental TetraFlex Study IOL

Intervention Type: DEVICE

TetraFlex IOL implanted

Control IOL

commercially approved PCIOL implanted

Group Type: ACTIVE_COMPARATOR

posterior chamber IOL implantation

Intervention Type: DEVICE

Interventions

posterior chamber IOL implantation

Intervention Type: DEVICE

Experimental TetraFlex Study IOL

TetraFlex IOL implanted

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lenstec Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald R Sanders, MD, PhD

Role: STUDY_DIRECTOR

Center for Clinical Research

Other Identifiers

IDE G050048

Identifier Type: -

Identifier Source: org_study_id