Assessment of Comfort Level Following an Intravitreal Injection by 30 or 32 Gauge Needles
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | July 2016 |
| Contact: | Gabriel M Gordon, Ph.D. |
| Email: | gabrielmgordon@gmail.com |
| Phone: | 805-895-6666 |
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.
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.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age > 18 years
- Subject's normal therapeutic regimen calls for them to receive two sessions of
bilateral injections of the same volume of ranibizumab within the next year.
- Disease related considerations: None.
- Other considerations: Subjects who must be able to report pain scores during and
up to 48 hours following an intravitreal injection. Also, subjects must consent
to at least 5 intraocular pressure checks per eye for each injection procedure.
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered
effective means of contraception: surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in
conjunction with spermicidal gel, an intrauterine device, or contraceptive hormone
implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated
- special classes of subjects (vulnerable subjects), such as fetuses, pregnant women,
children, institutionalized mentally disabled, or others, especially those whose
ability to give voluntary informed consent may be in question.
We found this trial at
1
site
Fort Myers, Florida 33907
Principal Investigator: Alexander M Eaton, M.D.
Phone: 805-895-6666
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