Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2011-08-31
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
27-gauge needle
27-gauge
27-gauge needle for IVT
Group 2
30-gauge needle
30-gauge
30-gauge needle for IVT
Interventions
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27-gauge
27-gauge needle for IVT
30-gauge
30-gauge needle for IVT
Eligibility Criteria
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Inclusion Criteria
* clinical significant macular edema due to diabetic retinopathy or other vascular disorders
* treatment with intravitreal therapy
Exclusion Criteria
* age under 50 years
51 Years
ALL
Yes
Sponsors
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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
OTHER
Responsible Party
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Dr. Christiane I. Falkner-Radler
Principial investigator
Principal Investigators
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Christiane I Falkner-Radler, MD
Role: PRINCIPAL_INVESTIGATOR
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Susanne Binder, MD
Role: STUDY_CHAIR
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Locations
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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25
Vienna, , Austria
Countries
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Other Identifiers
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FR-7-CI-2011
Identifier Type: -
Identifier Source: org_study_id
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