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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: posterior chamber IOL implantation; Device: Experimental TetraFlex Study IOL

• Registration Number: NCT00969371
• Lead Sponsor: Lenstec Incorporated

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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control IOL	posterior chamber IOL implantation	commercially approved PCIOL implanted
Lenstec Tetraflex IOL implantation	Experimental TetraFlex Study IOL	patients in Study arm received TetraFlex Lens

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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