Blue-Blocking IOLs in Combined Surgery

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)

Overall Status

Completed

CT.gov ID

NCT00537992

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Oct 1, 2004

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

complication rates and vitreoretinal diagnoses []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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