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| Name | Class |
|---|---|
| California Retina Consultants | OTHER |
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to determine if a smaller needle size reduces discomfort suffered by patients both during and following intravitreal injections. It is the investigators belief that using a smaller size needle will help patients to be less fearful of intravitreal injections and more amenable to treatment. This study will also evaluate the effect of needle size on post injection intraocular pressure, to see if smaller needles may reduce wound leak and increase the intraocular pressure following injection.
The investigators hypothesize that subject eyes injected with the smaller size needle will result in greater patient comfort both during and after their injection as compared to the eye injected with the larger needle. The investigators objective is to reduce any discomfort felt by patients who receive intravitreal injections. The investigators also hypothesize that the smaller needle will result in higher post injection pressures, and another objective is to determine if this can affect patient comfort and increase the risk of glaucomatous optic nerve damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye injection by 30 gauge needle | Active Comparator | Consented patients receiving monthly bi-lateral injections of the same dose of ranibizumab will have one eye injected with a 30 gauge needle and the other eye injected with a 32 gauge needle. Bi-lateral injections may be performed on the same day or with one week of each other, depending on the subject preference and their normal injection regimen. On the first visit following enrollment in the study, the eye to receive the injection from the 30 or 32 gauge needle will be determined randomly. The other eye will be injected with the other needle size (may be that day or within 1 week of the 1st injection). When the patient returns for their next set of bi-lateral injections, the eyes receiving the 30 and 32 gauge needle injection will switch. |
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| Eye injection by 32 gauge needle | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye injection by 30 or 32 gauge needle | Device | Consented patients receiving monthly bi-lateral injections of the same dose of ranibizumab will have one eye injected with a 30 gauge needle and the other eye injected with a 32 gauge needle. Bi-lateral injections may be performed on the same day or with one week of each other, depending on the subject preference and their normal injection regimen. On the first visit following enrollment in the study, the eye to receive the injection from the 30 or 32 gauge needle will be determined randomly. The other eye will be injected with the other needle size. When the patient returns for their next set of bi-lateral injections, the eyes receiving the 30 and 32 gauge needle injection will switch. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment. | Following each session of injections, the patient will be asked to fill out a short questionnaire regarding the comfort levels of the two needle sizes. Also, all subjects will be followed up by phone within 48 hours to assess any post-injection pain. | Immediately following an injection and follow-up within 48 hours of the injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure assessment | As a secondary end point, pre and post injection intraocular pressure measurements will also be taken prior to each intravitreal injection by tonopen, as well as at 1-, 3-, 10-, and 30- minutes post-Intravitreal injection. | 1 minute prior, as well as 1, 3, 10, and 30 minutes post-injection |
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Inclusion Criteria:
Ability to provide written informed consent and comply with study assessments for the full duration of the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel M Gordon, Ph.D. | Contact | 805-895-6666 | gabrielmgordon@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexander M Eaton, M.D. | Retina Health Center | Principal Investigator |
| Gabriel M Gordon, Ph.D. | Retina Health Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Health Center | Recruiting | Fort Myers | Florida | 33907 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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