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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014