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Blue-Blocking IOLs in Combined Surgery

Primary Purpose

Epiretinal Membranes, Macular Holes, Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
combined surgery
Sponsored by
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membranes focused on measuring combined surgery,, cataract surgery,, vitrectomy,, blue light-filter iols

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema)
  • Coexisting significant cataract
  • The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation)
  • Age over 50 years.

Exclusion Criteria:

  • Pseudophakia on the non-study eye
  • The need for silicone oil tamponade
  • Optic atrophy.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome

    Secondary Outcome Measures

    complication rates and vitreoretinal diagnoses

    Full Information

    First Posted
    October 1, 2007
    Last Updated
    October 1, 2007
    Sponsor
    The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00537992
    Brief Title
    Blue-Blocking IOLs in Combined Surgery
    Official Title
    Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.
    Detailed Description
    Sixty patients were randomly assigned to receive a UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure. Outcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epiretinal Membranes, Macular Holes, Cataract
    Keywords
    combined surgery,, cataract surgery,, vitrectomy,, blue light-filter iols

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    combined surgery
    Intervention Description
    UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure
    Primary Outcome Measure Information:
    Title
    intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome
    Secondary Outcome Measure Information:
    Title
    complication rates and vitreoretinal diagnoses

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema) Coexisting significant cataract The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation) Age over 50 years. Exclusion Criteria: Pseudophakia on the non-study eye The need for silicone oil tamponade Optic atrophy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susanne Binder, Prof., MD
    Organizational Affiliation
    Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Christiane I Falkner-Radler, MD
    Organizational Affiliation
    Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16597662
    Citation
    Hayashi K, Hayashi H. Visual function in patients with yellow tinted intraocular lenses compared with vision in patients with non-tinted intraocular lenses. Br J Ophthalmol. 2006 Aug;90(8):1019-23. doi: 10.1136/bjo.2006.090712. Epub 2006 Apr 5.
    Results Reference
    background
    PubMed Identifier
    16023990
    Citation
    Olson RJ, Werner L, Mamalis N, Cionni R. New intraocular lens technology. Am J Ophthalmol. 2005 Oct;140(4):709-16. doi: 10.1016/j.ajo.2005.03.061. Epub 2005 Jul 18.
    Results Reference
    background
    PubMed Identifier
    18191090
    Citation
    Falkner-Radler CI, Benesch T, Binder S. Blue light-filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. Am J Ophthalmol. 2008 Mar;145(3):499-503. doi: 10.1016/j.ajo.2007.10.021. Epub 2008 Jan 11.
    Results Reference
    derived

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    Blue-Blocking IOLs in Combined Surgery

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