Pain After Intravitreal Therapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01477996

Enrollment

200

Registered

2011-11-23

Start date

2011-08-31

Completion date

2011-12-31

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

intravitreal therapy, pain scales, gauge, Pain Scores, Visual Analog Scale

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.

Interventions

PROCEDURE27-gauge

27-gauge needle for IVT

PROCEDURE30-gauge

30-gauge needle for IVT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

51 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026