Pain After Intravitreal Therapy
This study is currently recruiting participants.
Verified November 2011 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by (Responsible Party):
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT01477996
First received: August 8, 2011
Last updated: November 22, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain |
Procedure: 27-gauge Procedure: 30-gauge |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 200 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
27-gauge needle
|
Procedure: 27-gauge
27-gauge needle for IVT
|
|
Active Comparator: Group 2
30-gauge needle
|
Procedure: 30-gauge
30-gauge needle 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.
Eligibility| Ages Eligible for Study: | 51 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477996
Contacts
| Contact: Christiane I Falkner-Radler, MD | 0043711654607 | christiane.falkner-radler@wienkav.at |
| Contact: Barbara Wimpissinger, MD | 0043711654607 | barbara.wimpissinger@wienkav.at |
Locations
| Austria | |
| 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 christiane.falkner-radler@wienkav.at | |
| Contact: Barbara Wimpissinger, MD 0043711654607 barbara.wimpissinger@wienkav.at | |
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Dr. Christiane I. Falkner-Radler, Principial investigator, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery |
| ClinicalTrials.gov Identifier: | NCT01477996 History of Changes |
| Other Study ID Numbers: | FR-7-CI-2011 |
| Study First Received: | August 8, 2011 |
| Last Updated: | November 22, 2011 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
|
intravitreal therapy pain scales gauge Pain Scores Visual Analog Scale |
ClinicalTrials.gov processed this record on May 19, 2013