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30g vs 33g Needle for Intravitreal Injections

Sponsor
Wills Eye (Other)
Overall Status
Completed
CT.gov ID
NCT03038048
Collaborator
Mid Atlantic Retina (Other)
50
Enrollment
1
Location
2
Arms
3
Actual Duration (Months)
16.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Varying needle size with intravitreal ranibizumab or aflibercept
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience
Actual Study Start Date :
Jan 27, 2017
Actual Primary Completion Date :
Apr 27, 2017
Actual Study Completion Date :
Apr 27, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Intraocular pressure 5 minutes post injection [Day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mid Atlantic Retina- Wills Eye Hospital Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Wills Eye
    • Mid Atlantic Retina

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MidAtlantic Retina, Allen Chiang, MD, Wills Eye
    ClinicalTrials.gov Identifier:
    NCT03038048
    Other Study ID Numbers:
    • 16-594E
    First Posted:
    Jan 31, 2017
    Last Update Posted:
    Jul 25, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration
    Macular Edema
    Retinal Vein Occlusion
    Ranibizumab
    Aflibercept

    Study Results

    No Results Posted as of Jul 25, 2017