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

NCT00969371 | Completed

• 1 other identifier: IDE G050048
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

posterior chamber intraocular lens; PCIOL; IOL

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

Lenstec Tetraflex IOL implantation

EXPERIMENTAL

patients in Study arm received TetraFlex Lens

Device: Experimental TetraFlex Study IOL

Control IOL

ACTIVE COMPARATOR

commercially approved PCIOL implanted

Device: posterior chamber IOL implantation

Interventions

posterior chamber IOL implantation DEVICE

Control IOL

Experimental TetraFlex Study IOL DEVICE

TetraFlex IOL implanted

Lenstec Tetraflex IOL implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lenstec Incorporated: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Donald R Sanders, MD, PhD

  Center for Clinical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: September 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 18, 2018

Record last verified: 2018-10