Pain After Intravitreal Therapy

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: 30-gauge; Procedure: 27-gauge

• Registration Number: NCT01477996
• Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Brief 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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-08
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2016-01-24
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	30-gauge	30-gauge needle
Group 1	27-gauge	27-gauge needle

Primary Outcome Measures

Name	Time	Method
Visual Analoge Scale	1 day, after the intravitreal therapy (IVT)	pain scores on the visual analog scale after the IVT

Secondary Outcome Measures

Name	Time	Method
Baker scale	1 day, after the intravitreal therapy (IVT)	pain scores on the baker scale after the IVT
patients demographic data	1 day, record of patients data before or after intravitreal therapy (IVT)	age, gender, number of IVT, surgeon, prior surgical procedures

Trial Locations

Locations (1)

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