Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye
Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection|
- Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection [ Time Frame: immediately after injection, 1- hour later, and next day ] [ Designated as safety issue: No ]
Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe
Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied
- Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg [ Time Frame: immediately after injection, at 5, 10, 15 minutes ] [ Designated as safety issue: Yes ]intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection.
- Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage [ Time Frame: within 10 minutes of the injection ] [ Designated as safety issue: Yes ]
Presence of corneal staining after the injection:
- Quadrants of fluorescein staining: 0 1 2 3 4
- Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion
Size of subconjunctival hemorrhage:
in clock hours
|Study Start Date:||April 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: 4% lidocaine
Eyes were anesthetized with 0.5% proparacaine and then with three cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of the injection inferotemporally to the limbus. Each participant was assigned to have this prep during one of the consecutive study visits if unilateral or in one eye if patient requires bilateral injections given the same day
Drug: 4% lidocaine
The eye will be topically anesthetized with 0.5% proparacaine drops and 4% lidocaine drops and a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface followed in three rounds by additional 5% povidone iodine and a sterile cotton swab soaked in sterile 4% lidocaine applied with gentle pressure to the area designated for injection in the infero-temporal quadrant.
Other Name: lidocaine
Experimental: 3.5% ophthalmic lidocaine gel
Eye was anesthetized with 0.5% proparacaine and then with 3.5% ophthalmic lidocaine gel applied to the surface of the eye. Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
Drug: 3.5% ophthalmic lidocaine gel
The eye will be topically anesthetized with 0.5% proparacaine drops and 5% povidone iodine will be placed over the eye. Two drops of preservative-free 3.5% lidocaine hydrochloride ophthalmic gel will be placed into inferior conjunctival sac. The patient will be asked to close the eye for 7 minutes. Next, a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface and allowed to remain in contact with the eye for at least 2 minutes. The eye will then be rinsed with antibiotic drops.
Other Name: Akten
The primary goal of this investigation is to determine the relative comfort of an intravitreal injection (same day and the next day) after a preparation utilizing three cotton swabs soaked in 4% lidocaine versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel. Based on the available data, the researchers contend that a preparation based on viscous 3.5% ophthalmic lidocaine gel, which coats the surface and remains in contact with the eye longer, may provide greater anesthesia and result in greater patient comfort than the topical 4% lidocaine, which is part of the standard preparation routinely utilized in the ophthalmology department currently. Secondary outcome measure is the intraocular pressure rise after the injection, and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike.
|United States, Florida|
|Miami Veterans Affairs Medical Center|
|Miami, Florida, United States, 33125|
|Principal Investigator:||Ninel Gregori, MD||Miami VA Healthcare Systems|