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Pain After Intravitreal Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477996
First Posted: November 23, 2011
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
  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 (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Dr. Christiane I. Falkner-Radler, 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) ]
    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) ]
    age, gender, number of IVT, surgeon, prior surgical procedures

  • Baker scale [ Time Frame: 1 day, after the intravitreal therapy (IVT) ]
    pain scores on the baker scale after the IVT


Enrollment: 200
Study Start Date: August 2011
Study Completion Date: December 2011
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

Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477996


Locations
Austria
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25
Vienna, Austria, 1030
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

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
First Submitted: August 8, 2011
First Posted: November 23, 2011
Last Update Posted: January 26, 2016
Last Verified: November 2011

Keywords provided by Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
intravitreal therapy
pain scales
gauge
Pain Scores
Visual Analog Scale