30g vs 33g Needle for Intravitreal Injections

W

Wills Eye

Status

Completed

Conditions

Age Related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion

Treatments

Procedure: Varying needle size with intravitreal ranibizumab or aflibercept

Study type

Interventional

Funder types

Other

Identifiers

NCT03038048
16-594E

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

50 participants in 2 patient groups

33 g needle - right eye
Experimental group
Description:
33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye
Treatment:
Procedure: Varying needle size with intravitreal ranibizumab or aflibercept
33 g needle - left eye
Experimental group
Description:
33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye
Treatment:
Procedure: Varying needle size with intravitreal ranibizumab or aflibercept

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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