Viewing Study NCT00537992


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Study NCT ID: NCT00537992
Status: COMPLETED
Last Update Posted: 2007-10-02
First Post: 2007-10-01
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Blue-Blocking IOLs in Combined Surgery
Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Organization:

Study Overview

Official Title: Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.
Status: COMPLETED
Status Verified Date: 2007-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: