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NCT01477996 Clinical Trial

Pain After Intravitreal Therapy

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01477996
Other study ID # FR-7-CI-2011
Secondary ID
Status Completed
Phase N/A
First received August 8, 2011
Last updated January 24, 2016
Start date August 2011
Est. completion date December 2011

Study information
Verified date November 2011
Source The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 51 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• 27-gauge
27-gauge needle for IVT
• 30-gauge
30-gauge needle for IVT

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

Sponsors (1)
Lead Sponsor Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analoge Scale pain scores on the visual analog scale after the IVT 1 day, after the intravitreal therapy (IVT) No
Secondary patients demographic data age, gender, number of IVT, surgeon, prior surgical procedures 1 day, record of patients data before or after intravitreal therapy (IVT) No
Secondary Baker scale pain scores on the baker scale after the IVT 1 day, after the intravitreal therapy (IVT) No
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