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Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT01202981
Collaborator
(none)
200
Enrollment
1
Location
35
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. The primary objective is to determine if random light scattering (measured by C-Quant)correlates with severity of glistenings, other objective measures of visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with glare), and subjective measures of patients' perceptions of their visual quality after cataract surgery (quality of life survey, reports of symptomology and satisfaction).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Impact of IOL Glistenings on Visual Quality and Function in Patients Implanted With a Single-Piece AcrySof IOL That Exhibits Glistening Formation
    Study Start Date :
    Jul 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Jun 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Patients who had cataract surgery by the Investigators between July 1, 2007 and June 30, 2008.
    Group 2

    Patients who had cataract surgery by the Investigators between July 1, 2008 and July 1, 2009.

    Outcome Measures

    Primary Outcome Measures

    1. Light scattering [Post-opertative]

      Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses

    Secondary Outcome Measures

    1. Visual function [Post-operative]

      Correlation of visual function (visual acuity, contrast acuity and constrast acuity with glare)with glistening severity

    2. Visual quality [Post-operative]

      Correlation of visual quality (measured with quality of life questionnaire, and subjective reports of symptoms) with glistening severity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Presence of obvious glistenings by slit lamp exam

    2. Best spectacle corrected visual acuity of 20/20 or better on the Snellen chart at most recent exam

    Exclusion Criteria:

    1. Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.

    2. Any documented glaucoma of any kind.

    3. Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.

    4. Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.

    5. Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.

    6. Diagnosis of dry eye syndrome, defined as any corneal staining with fluorescein

    7. Presence of any central posterior capsular opacification. Previous YAG laser capsulotomy is allowed.

    8. Any surgical complication having to do with the capsule such as a broken capsule or zonular dialysis or iris trauma or any other complication felt to in any way impact upon the quality of the visual result.

    9. Any contraindication to pupil dilation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah, John Moran Eye Center Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Randall J Olson, MD, University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Utah
    ClinicalTrials.gov Identifier:
    NCT01202981
    Other Study ID Numbers:
    • 42093
    First Posted:
    Sep 16, 2010
    Last Update Posted:
    Dec 11, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by University of Utah
    glistenings
    contrast sensitivity
    visual quality
    straylight
    AcrySof IOL

    Study Results

    No Results Posted as of Dec 11, 2014