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Blue-Blocking IOLs in Combined Surgery

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ClinicalTrials.gov Identifier: NCT00537992
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : October 2, 2007
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Condition or disease Intervention/treatment Phase
Epiretinal Membranes Macular Holes Cataract Procedure: combined surgery Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.
Study Start Date : October 2004
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources


Intervention Details:
    Procedure: combined surgery
    UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure


Primary Outcome Measures :
  1. intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome

Secondary Outcome Measures :
  1. complication rates and vitreoretinal diagnoses


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537992


Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Principal Investigator: Susanne Binder, Prof., MD Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Study Director: Christiane I Falkner-Radler, MD Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00537992     History of Changes
Other Study ID Numbers: FR-CI-03-2007
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: October 2007

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
combined surgery,
cataract surgery,
vitrectomy,
blue light-filter iols

Additional relevant MeSH terms:
Cataract
Retinal Perforations
Epiretinal Membrane
Lens Diseases
Eye Diseases
Retinal Diseases