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Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence

Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT01191502
Collaborator
(none)
50
Enrollment
1
Location
20
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Comparative Study of Photopic and Mesopic Distance Intermediate and Near Visual Acuity, and Spectacle Independence With Binocular Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens HD (CHD) Intraocular Lens
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Sep 1, 2011
    Actual Study Completion Date :
    Sep 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS
    CRYSTALENS HD (CHD) INTRAOCULAR LENS

    Outcome Measures

    Primary Outcome Measures

    1. Manifest refraction (monocular) [1 year]

    2. Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular) [1 year]

    3. Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular) [1 year]

    4. Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular) [1 year]

    5. Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular) [1 year]

    6. Photopic and mesopic pupillometry [1 year]

    Eligibility Criteria

    Criteria

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

    • 18 years of age or older

    • Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ HD Accommodating IOL

    • Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye

    • Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes

    • Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)

    • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

    Exclusion Criteria:

    • Ocular disease which could potentially limit uncorrected visual acuity or visual performance.

    • Use of systemic or ocular medications that may affect visual outcomes

    • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)

    • Uncontrolled systemic or ocular disease

    • History of ocular trauma

    • History of ocular surgery other than that required for inclusion in this study

    • Amblyopia or strabismus

    • Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)

    • Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30

    • Subjects who may be expected to require retinal laser treatment or other surgical intervention

    • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)

    • Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Sciences University Eugene, Oregon United States 97401

    Sponsors and Collaborators

    • Innovative Medical

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01191502
    Other Study ID Numbers:
    • TMF-09-002
    First Posted:
    Aug 30, 2010
    Last Update Posted:
    Oct 6, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by , ,
    Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

    Study Results

    No Results Posted as of Oct 6, 2011