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30g vs 33g Needle for Intravitreal Injections

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03038048
Enrollment
50
Registered
2017-01-31
Start date
2017-01-27
Completion date
2017-04-27
Last updated
2017-07-25

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

Conditions

Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREVarying needle size with intravitreal ranibizumab or aflibercept

Varying gauge of needle, 33 gauge vs 30 gauge

Sponsors

Mid Atlantic Retina
CollaboratorOTHER
Wills Eye
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Difference in discomfort between 30g and 33g needleDay 1Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections

Secondary

MeasureTime frame
Intraocular pressure 5 minutes post injectionDay 1

Countries

United States

Outcome results

None listed

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