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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
posterior chamber IOL implantation
Experimental TetraFlex Study IOL
Sponsored by
Lenstec Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring posterior chamber intraocular lens, PCIOL, IOL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lenstec Tetraflex IOL implantation

    Control IOL

    Arm Description

    patients in Study arm received TetraFlex Lens

    commercially approved PCIOL implanted

    Outcomes

    Primary Outcome Measures

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

    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.

    Full Information

    First Posted
    August 31, 2009
    Last Updated
    October 17, 2018
    Sponsor
    Lenstec Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00969371
    Brief Title
    Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) Clinical Investigation
    Official Title
    Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL)Clinical Investigation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lenstec Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    posterior chamber intraocular lens, PCIOL, IOL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    470 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lenstec Tetraflex IOL implantation
    Arm Type
    Experimental
    Arm Description
    patients in Study arm received TetraFlex Lens
    Arm Title
    Control IOL
    Arm Type
    Active Comparator
    Arm Description
    commercially approved PCIOL implanted
    Intervention Type
    Device
    Intervention Name(s)
    posterior chamber IOL implantation
    Intervention Type
    Device
    Intervention Name(s)
    Experimental TetraFlex Study IOL
    Intervention Description
    TetraFlex IOL implanted
    Primary Outcome Measure Information:
    Title
    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
    Title
    The primary safety outcome is the incidence/severity of adverse events and complications.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald R Sanders, MD, PhD
    Organizational Affiliation
    Center for Clinical Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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