Pain After Intravitreal Therapy

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status: Completed

Conditions: Pain

Treatments: Procedure: 30-gauge; Procedure: 27-gauge

Study type: Interventional

Funder types: Other

Identifiers

NCT01477996

FR-7-CI-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 51+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Group 1

Active Comparator group

Description:

27-gauge needle

Treatment:

Procedure: 27-gauge

Group 2

Active Comparator group

Description:

30-gauge needle

Treatment:

Procedure: 30-gauge