Pain After Intravitreal Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Visual Analoge Scale
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 51 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •vitrearetinal disease including age-related macular degeneration,
- •clinical significant macular edema due to diabetic retinopathy or other vascular disorders
- •treatment with intravitreal therapy
Exclusion Criteria
- •missing informed consent
- •age under 50 years
Outcomes
Primary Outcomes
Visual Analoge Scale
Time Frame: 1 day, after the intravitreal therapy (IVT)
pain scores on the visual analog scale after the IVT
Secondary Outcomes
- Baker scale(1 day, after the intravitreal therapy (IVT))
- patients demographic data(1 day, record of patients data before or after intravitreal therapy (IVT))
Investigators
Dr. Christiane I. Falkner-Radler
Principial investigator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery