Pain After Intravitreal Therapy

January 24, 2016 updated by: Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analoge Scale
Time Frame: 1 day, after the intravitreal therapy (IVT)
pain scores on the visual analog scale after the IVT
1 day, after the intravitreal therapy (IVT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day, record of patients data before or after intravitreal therapy (IVT)
Baker scale
Time Frame: 1 day, after the intravitreal therapy (IVT)
pain scores on the baker scale after the IVT
1 day, after the intravitreal therapy (IVT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 24, 2016

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FR-7-CI-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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