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Blue-Blocking IOLs in Combined Surgery

This study has been completed.
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00537992
First received: October 1, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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 Intervention
Epiretinal Membranes
Macular Holes
Cataract
 Procedure: combined surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

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

Secondary Outcome Measures:
  • complication rates and vitreoretinal diagnoses

Enrollment: 60
Study Start Date: October 2004
Study Completion Date: March 2006
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
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Additional 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
Study First Received: October 1, 2007
Last Updated: October 1, 2007
Health Authority: Austria: Ethikkommission

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:
Retinal Perforations
Cataract
Epiretinal Membrane
 Retinal Diseases
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 16, 2013