Pain After Intravitreal Therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
- Visual Analoge Scale [ Time Frame: 1 day, after the intravitreal therapy (IVT) ] [ Designated as safety issue: No ]pain scores on the visual analog scale after the IVT
- patients demographic data [ Time Frame: 1 day, record of patients data before or after intravitreal therapy (IVT) ] [ Designated as safety issue: No ]age, gender, number of IVT, surgeon, prior surgical procedures
- Baker scale [ Time Frame: 1 day, after the intravitreal therapy (IVT) ] [ Designated as safety issue: No ]pain scores on the baker scale after the IVT
|Study Start Date:||August 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Group 1
27-gauge needle for IVT
Active Comparator: Group 2
30-gauge needle for IVT
Purpose: To evaluate the influence of the type of the needle on pain scores after intravitreal therapy (IVT).
Design: Randomized clinical trial Methods: A total of 200 patients, treated with an IVT for exudative age-related macular degeneration (AMD) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). After IVt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure.
Regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during IVT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477996
|The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25|
|Vienna, Austria, 1030|
|Principal Investigator:||Christiane I Falkner-Radler, MD||The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery|
|Study Chair:||Susanne Binder, MD||The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery|