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Pain After Intravitreal Therapy

This study has been completed.
Sponsor:
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: January 24, 2016
Last verified: November 2011
  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


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

Ages Eligible for Study:   51 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 8, 2011
Last Updated: January 24, 2016
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 December 07, 2016