30g vs 33g Needle for Intravitreal Injections

Not Applicable

Completed

• Conditions: Diabetic Macular Edema; Retinal Vein Occlusion; Age Related Macular Degeneration
• Interventions: Procedure: Varying needle size with intravitreal ranibizumab or aflibercept

• Registration Number: NCT03038048
• Lead Sponsor: Wills Eye

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.

Study Timeline

• Study Start: 2017-01-27
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2017-04-27
• Study Completion: 2017-04-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
33 g needle - left eye	Varying needle size with intravitreal ranibizumab or aflibercept	33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye
33 g needle - right eye	Varying needle size with intravitreal ranibizumab or aflibercept	33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye

Primary Outcome Measures

Name	Time	Method
Difference in discomfort between 30g and 33g needle	Day 1	Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure 5 minutes post injection	Day 1

Trial Locations

Locations (1)

Mid Atlantic Retina- Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States