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Clinical Trials/NCT00537992
NCT00537992
Completed
Not Applicable

Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery0 sites60 target enrollmentOctober 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epiretinal Membranes
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Enrollment
60
Primary Endpoint
intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2004
End Date
March 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • complication rates and vitreoretinal diagnoses

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