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| Name | Class |
|---|---|
| Mid Atlantic Retina | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 33 g needle - right eye | Experimental | 33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye |
|
| 33 g needle - left eye | Experimental | 33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varying needle size with intravitreal ranibizumab or aflibercept | Procedure | Varying gauge of needle, 33 gauge vs 30 gauge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in discomfort between 30g and 33g needle | Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure 5 minutes post injection | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Chiang, MD | Mid Atlantic Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid Atlantic Retina- Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| D013927 |
| Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |