30g vs 33g Needle for Intravitreal Injections

July 21, 2017 updated by: MidAtlantic Retina, Wills Eye

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina- Wills Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 33 g needle - right eye
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
Varying gauge of needle, 33 gauge vs 30 gauge
Other Names:
  • Lucentis, Eylea
Experimental: 33 g needle - left eye
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
Varying gauge of needle, 33 gauge vs 30 gauge
Other Names:
  • Lucentis, Eylea

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure 5 minutes post injection
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Collaborators

Mid Atlantic Retina

Investigators

  • Principal Investigator: Allen Chiang, MD, Mid Atlantic Retina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2017

Primary Completion (Actual)

April 27, 2017

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-594E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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