30g vs 33g Needle for Intravitreal Injections

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038048
• Other study ID #: 16-594E
• Status: Completed
• Phase: N/A
• First received: January 27, 2017
• Last updated: July 21, 2017
• Start date: January 27, 2017
• Est. completion date: April 27, 2017

Study information

• Verified date: July 2017
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Varying needle size with intravitreal ranibizumab or aflibercept
Varying gauge of needle, 33 gauge vs 30 gauge

Locations

Country	Name	City	State
United States	Mid Atlantic Retina- Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Mid Atlantic Retina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in discomfort between 30g and 33g needle	Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections	Day 1
Secondary	Intraocular pressure 5 minutes post injection		Day 1