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NCT Number: NCT01477996

Pain After Intravitreal Therapy

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

51 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, 1030, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

27-gauge

Procedure

27-gauge needle for IVT

30-gauge

Procedure

30-gauge needle for IVT

Primary outcomes

  1. Visual Analoge Scale

    Time frame: 1 day, after the intravitreal therapy (IVT)

    pain scores on the visual analog scale after the IVT

Secondary outcomes

  1. 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

  2. Baker scale

    Time frame: 1 day, after the intravitreal therapy (IVT)

    pain scores on the baker scale after the IVT

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2011
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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