Pain After Intravitreal Therapy
Recruitment status was Recruiting
This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.
|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|
|Estimated Study Completion Date:||December 2011|
|Estimated 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
|Contact: Christiane I Falkner-Radler, MDfirstname.lastname@example.org|
|Contact: Barbara Wimpissinger, MDemail@example.com|
|The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25||Recruiting|
|Vienna, Austria, 1030|
|Contact: Christiane I Falkner-Radler, MD 0043711654607 firstname.lastname@example.org|
|Contact: Barbara Wimpissinger, MD 0043711654607 email@example.com|
|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|