30g vs 33g Needle for Intravitreal Injections

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Varying needle size with intravitreal ranibizumab or aflibercept


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 33 g needle - right eye<br>33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye | Procedure: Varying needle size with intravitreal ranibizumab or aflibercept<br>* Varying gauge of needle, 33 gauge vs 30 gauge<br>* Other names: Lucentis, Eylea;|
| Experimental: 33 g needle - left eye<br>33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye | Procedure: Varying needle size with intravitreal ranibizumab or aflibercept<br>* Varying gauge of needle, 33 gauge vs 30 gauge<br>* Other names: Lucentis, Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in discomfort between 30g and 33g needle | Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure 5 minutes post injection |  | Day 1 |