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OpenTrials
Completed

NCT Number: NCT03038048

30g vs 33g Needle for Intravitreal Injections

We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.

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Key information

Conditions

Age Related Macular Degeneration Cardiovascular Diseases Diabetic Macular Edema Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid Atlantic Retina- Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

This is a prospective, randomized, interventional pilot study, which seeks to compare the patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal injections of ranibizumab or aflibercept for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal vein occlusion (RVO). The null hypothesis is that there is no difference in patient discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema

Exclusion criteria

  • 1) Patients who do not receive Betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) Patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).

Treatment and study plan

Varying needle size with intravitreal ranibizumab or aflibercept

Procedure

Varying gauge of needle, 33 gauge vs 30 gauge

Other names: Lucentis, Eylea

Primary outcomes

  1. Difference in discomfort between 30g and 33g needle

    Time frame: Day 1

    Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections

Secondary outcomes

  1. Intraocular pressure 5 minutes post injection

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Mid Atlantic Retina

Registry information

Official study title

Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2017
Registry last updated
Jul 25, 2017

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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