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Post-Implant Performance of the EC-3 IOL

Sponsor
Aaren Scientific Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01333345
Collaborator
(none)
100
Enrollment
3
Locations
2
Duration (Months)
33.3
Patients Per Site
16.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Anomalies include, but are not limited to:

    Posterior Capsule Opacification (PCO) (pathological condition) - delayed clouding of the lens capsule after cataract surgery.

    Glistenings - fluid-filled micro-vacuoles that form within the intraocular lens (IOL) optic when the IOL is in an aqueous environment. They may appear to be on the lens surface.

    Artifacts - glares, halos, starbursts and/or shadows caused by IOLs.

    Fibrosis - the formation of fibrous connective tissue, as in a scar.

    Glare - undesirable sensation produced by brightness that is much greater than that to which the eyes are adapted. Causes annoyance, discomfort, or loss in visual performance.

    Halos (symptom) - the appearance of hazy ring(s) around light.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens
    Study Start Date :
    Apr 1, 2011
    Anticipated Primary Completion Date :
    Jun 1, 2011
    Anticipated Study Completion Date :
    Jun 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens. [2-3 years post-implantation]

      Routine eye exam by the investigator.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Enrollment in the EC-3 clinical trial

    • Subjects who were implanted with EC-3 IOL

    Exclusion Criteria:
    • Removal of the EC-3 IOL at any time

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stephenson Eye Associates Venice Florida United States 34285
    2 Eyesight Ophthalmic Services Dover New Hampshire United States 03820
    3 Cabinet d'Ophtalmologie du Dr. Pey Le Puy en Velay France 43000

    Sponsors and Collaborators

    • Aaren Scientific Inc.

    Investigators

    • Principal Investigator: P. Dee G. Stephenson, M.D., Stephenson Eye Associates
    • Principal Investigator: N. Timothy Peters, M.D., Eyesight Ophthalmic Services PA
    • Principal Investigator: Christophe Pey, M.D., Cabinet d'Ophtalmologie du Dr. Pey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01333345
    Other Study ID Numbers:
    • DC-036 Addendum
    First Posted:
    Apr 12, 2011
    Last Update Posted:
    Apr 12, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    Cataract replacement surgery
    implantation
    EC-3 IOL
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Apr 12, 2011