Back to results30g vs 33g Needle for Intravitreal Injections
Primary Purpose
Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Varying needle size with intravitreal ranibizumab or aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration
Eligibility Criteria
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).
Sites / Locations
- Mid Atlantic Retina- Wills Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
33 g needle - right eye
33 g needle - left eye
Arm Description
33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye
33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye
Outcomes
Primary Outcome Measures
Difference in discomfort between 30g and 33g needle
Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections
Secondary Outcome Measures
Intraocular pressure 5 minutes post injection
Full Information
NCT ID
NCT03038048
First Posted
January 27, 2017
Last Updated
July 21, 2017
Sponsor
Wills Eye
Collaborators
Mid Atlantic Retina
1. Study Identification
Unique Protocol Identification Number
NCT03038048
Brief Title
30g vs 33g Needle for Intravitreal Injections
Official Title
Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
April 27, 2017 (Actual)
Study Completion Date
April 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Mid Atlantic Retina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
33 g needle - right eye
Arm Type
Experimental
Arm Description
33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye
Arm Title
33 g needle - left eye
Arm Type
Experimental
Arm Description
33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye
Intervention Type
Procedure
Intervention Name(s)
Varying needle size with intravitreal ranibizumab or aflibercept
Other Intervention Name(s)
Lucentis, Eylea
Intervention Description
Varying gauge of needle, 33 gauge vs 30 gauge
Primary Outcome Measure Information:
Title
Difference in discomfort between 30g and 33g needle
Description
Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Intraocular pressure 5 minutes post injection
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Chiang, MD
Organizational Affiliation
Mid Atlantic Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid Atlantic Retina- Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
30g vs 33g Needle for Intravitreal Injections
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