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Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens

Primary Purpose

Cataract Extraction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acrysof single piece (SA60AT)
Acrysof IQ (SN60WF)
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Extraction

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Unilateral or bilateral cataract Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye. Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral. Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line. Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes. Exclusion Criteria: Preoperative ocular pathology potentially affecting visual acuity Previous intraocular or corneal surgery. Keratometric astigmatism exceeding 1.5 diopters. Planned postoperative refraction for mono-vision. Current contact lens usage. Other ocular surgery at the time of the cataract extraction. Uncontrolled diabetes. Any neurological condition that might interfere with performance of required test. Auto-immune deficiency disease. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results. Use of any systemic or topical drug known to interfere with visual performance. Surgical Exclusion Criteria Significant anterior chamber bleeding. Detached Descemet's membrane Iris damage Posterior capsule rupture Radial tear in capsulorhexis Vitreous loss Zonular rupture. Use of corneal sutures for more than 1 week. Post-implantation Exclusion Criteria Haptic not in the capsular bag. Descentration of the IOL of more than 1.0 mm Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Contrast sensitivity
    Visual acuity

    Secondary Outcome Measures

    Induction of hight order aberrations
    Corneal topography
    Patient satisfaction

    Full Information

    First Posted
    August 17, 2006
    Last Updated
    August 17, 2006
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00366496
    Brief Title
    Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens
    Official Title
    Comparison of Visual Outcomes, Wavefront Analysis, Contrast Sensitivity and Glare Testing Following Cataract Extraction Between Acrysof Single-Piece IOL and Acrysof WF
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    5. Study Description

    Brief Summary
    To determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract Extraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Acrysof single piece (SA60AT)
    Intervention Type
    Device
    Intervention Name(s)
    Acrysof IQ (SN60WF)
    Primary Outcome Measure Information:
    Title
    Contrast sensitivity
    Title
    Visual acuity
    Secondary Outcome Measure Information:
    Title
    Induction of hight order aberrations
    Title
    Corneal topography
    Title
    Patient satisfaction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unilateral or bilateral cataract Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye. Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral. Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line. Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes. Exclusion Criteria: Preoperative ocular pathology potentially affecting visual acuity Previous intraocular or corneal surgery. Keratometric astigmatism exceeding 1.5 diopters. Planned postoperative refraction for mono-vision. Current contact lens usage. Other ocular surgery at the time of the cataract extraction. Uncontrolled diabetes. Any neurological condition that might interfere with performance of required test. Auto-immune deficiency disease. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results. Use of any systemic or topical drug known to interfere with visual performance. Surgical Exclusion Criteria Significant anterior chamber bleeding. Detached Descemet's membrane Iris damage Posterior capsule rupture Radial tear in capsulorhexis Vitreous loss Zonular rupture. Use of corneal sutures for more than 1 week. Post-implantation Exclusion Criteria Haptic not in the capsular bag. Descentration of the IOL of more than 1.0 mm Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kerry D. Solomon, MD
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens

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