An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses

Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT01004549
Collaborator
(none)
30
Enrollment
1
Location
20
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Oct 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    ArmIntervention/Treatment
    Bilateral intraocular lens implantation.

    Outcome Measures

    Primary Outcome Measures

    1. Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading [one study visit]

    Secondary Outcome Measures

    1. Amplitude of accommodation on pushdown test - and how it compares to the COAS test results [one study visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients age 18 and older

    • Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:

    • Crystalens

    • Crysalens HD

    • Tecnis One monofocal

    • Patients must have a healthy cornea and macula

    • Patients must have 20/25 or better best corrected vision

    • Able to provide written informed consent

    Exclusion Criteria:
    • BCVA of less than 20/25

    • On oral medications that could potentially block accommodation:

    • First generation antihistamines

    • Anticholinergic agents

    • Anti-psychotic medications

    • Antidepressant medications

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1The Center for Excellence in Eye CareMiamiFloridaUnited States

    Sponsors and Collaborators

    • Innovative Medical

    Investigators

    • Principal Investigator: William Trattler, MD, The Center for Excellence in Eye Care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01004549
    Other Study ID Numbers:
    • Accomodation study
    First Posted:
    Oct 30, 2009
    Last Update Posted:
    Jun 28, 2011
    Last Verified:
    Jun 1, 2011

    Study Results

    No Results Posted as of Jun 28, 2011