Clinical trial NCT02142114: Assessment of Comfort Level Following an Intravitreal Injection by 30 or 32 Gauge Needles
Official title: Assessment of Comfort Level Following an Intravitreal Injection by 30 or 32 Gauge Needles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Intravitreal injection
Needle size
Pain
Intraocular pressure
Pain following an Intravitreal injection
Lead sponsor: Retina Health Center
Sponsor class: INDUSTRY
Collaborators: name: California Retina Consultants
name: Genentech, Inc.
First posted: 2014-05-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain assessment.
timeFrame: Immediately following an injection and follow-up within 48 hours of the injection.
Secondary outcomes:
measure: Intraocular pressure assessment
timeFrame: 1 minute prior, as well as 1, 3, 10, and 30 minutes post-injection
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Retina Health Center
state: Florida
Study officials:
affiliation: Retina Health Center
name: Alexander M Eaton, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Health Center
name: Gabriel M Gordon, Ph.D.
role: STUDY_DIRECTOR
References: