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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 27-gauge needle |
|
| Group 2 | Active Comparator | 30-gauge needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 27-gauge | Procedure | 27-gauge needle for IVT |
| |
| 30-gauge |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analoge Scale | pain scores on the visual analog scale after the IVT | 1 day, after the intravitreal therapy (IVT) |
| Measure | Description | Time Frame |
|---|---|---|
| patients demographic data | age, gender, number of IVT, surgeon, prior surgical procedures | 1 day, record of patients data before or after intravitreal therapy (IVT) |
| Baker scale | pain scores on the baker scale after the IVT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane I Falkner-Radler, MD | The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery | Principal Investigator |
| Susanne Binder, MD | The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25 | Vienna | 1030 | Austria |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Procedure |
30-gauge needle for IVT |
|
| 1 day, after the intravitreal therapy (IVT) |