Blue-Blocking IOLs in Combined Surgery

Not Applicable

Completed

• Conditions: Epiretinal Membranes; Macular Holes; Cataract

• Registration Number: NCT00537992
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-10
• Study Completion: 2006-03
• Status Verified: 2007-10
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Last Update Submitted: 2007-10-01
• Study First Posted: 2007-10-02
• Last Update Posted: 2007-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
complication rates and vitreoretinal diagnoses