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

This study has been completed.
Sponsor:
Information provided by:
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT00969371
First received: August 31, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Cataract
Device: posterior chamber IOL implantation
Device: Experimental TetraFlex Study IOL

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL)Clinical Investigation

Further study details as provided by Lenstec Incorporated:

Primary Outcome Measures:
  • The primary efficacy outcome is the assessment of the % of eyes obtaining 20/40 or better distance best corrected visual acuity. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The primary safety outcome is the incidence/severity of adverse events and complications. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 470
Study Start Date: September 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tetraflex Study
patients in Study arm received TetraFlex Lens
Device: Experimental TetraFlex Study IOL
TetraFlex IOL implanted
Active Comparator: Control
commercially approved PCIOL implanted
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969371

Sponsors and Collaborators
Lenstec Incorporated
Investigators
Study Director: Donald R Sanders, MD, PhD Center for Clinical Research
  More Information

No publications provided

Responsible Party: Jimmy Chacko Vice President of Regulatory Affairs, Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT00969371     History of Changes
Other Study ID Numbers: IDE G050048
Study First Received: August 31, 2009
Last Updated: August 31, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Lenstec Incorporated:
posterior chamber intraocular lens
PCIOL
IOL

ClinicalTrials.gov processed this record on October 20, 2014