Trial Outcomes & Findings for Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye (NCT NCT01087489)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

immediately after injection, 1- hour later, and next day

Results posted on

2012-11-20

Participant Flow

Miami VA Medical Center retina injection clinic; patients needing frequent intravitreal injections of ranibizumab were approached and recruited between April 2010 and March 2011

Patients were randomized upon recruitment and received the first anesthetic method on the day of recruitment, no wash out or transitional periods were necessary

Participant milestones

Participant milestones
Measure	Bilateral Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other.	Unilateral Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit.
Overall Study STARTED	19	34
Overall Study COMPLETED	19	31
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Bilateral Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other.	Unilateral Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit.
Overall Study enrolled in another VA study	0	1
Overall Study Death	0	1
Overall Study unable to survey by telephone	0	1

Baseline Characteristics

Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=53 Participants Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants
Age Continuous	74 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately after injection, 1- hour later, and next day

Population: all 50 patients who completed the study were included in the analysis, each patient received both anesthetic preparations prior to two consecutive (if unilateral disease) intravitreal injections on consecutive visits or in fellow eyes (if bilaterla disease) on the same day

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

Outcome measures

Outcome measures
Measure	4% Liquid Lidocaine Method n=50 Participants 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. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.	3.5% Ophthalmic Lidocaine Gel n=50 Participants 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. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection Discomfort during anesthetic preparation	2.1 units on a scale Standard Deviation 1.1	2.09 units on a scale Standard Deviation 0.8
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection Discomfort during needle penetration	1.7 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 0.9
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection Satisfaction with entire prep and injection	4.3 units on a scale Standard Deviation 1.0	4.5 units on a scale Standard Deviation 0.8
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection Discomfort 1 h after injection	2.4 units on a scale Standard Deviation 1.0	2.1 units on a scale Standard Deviation 1.1
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection Discomfort day after injection	1.8 units on a scale Standard Deviation 0.8	1.6 units on a scale Standard Deviation 0.8
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection Next day satisfaction with injection	4.3 units on a scale Standard Deviation 1.0	4.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: immediately after injection, at 5, 10, 15 minutes

Population: 48 participants were included in each arm, i.e. each participant received both methods, one eye twice if unilateral or both eyes if bilateral disease were randomily assigned to alternate prep on consecutive or same visit respectively

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.

Outcome measures

Outcome measures
Measure	4% Liquid Lidocaine Method n=48 eyes 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. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.	3.5% Ophthalmic Lidocaine Gel n=48 eyes 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. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg baseline IOP before injection	15.5 mmHg Standard Deviation 3.3	15.9 mmHg Standard Deviation 3.0
Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg IOP change after 0.05 cc injection	25.7 mmHg Standard Deviation 9.2	30.9 mmHg Standard Deviation 9.9

SECONDARY outcome

Timeframe: within 10 minutes of the injection

Population: all eyes for which data were available were included

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

Outcome measures

Outcome measures
Measure	4% Liquid Lidocaine Method n=49 eyes 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. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.	3.5% Ophthalmic Lidocaine Gel n=49 eyes 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. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage Corneal fluorescein staining	3.0 units on a scale Standard Deviation 1.0	2.3 units on a scale Standard Deviation 1.3
Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage Density of corneal staining	1.9 units on a scale Standard Deviation 0.7	1.3 units on a scale Standard Deviation 0.7

Adverse Events

4% Liquid Lidocaine Method

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

3.5% Ophthalmic Lidocaine Gel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	4% Liquid Lidocaine Method n=53 participants at risk 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. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.	3.5% Ophthalmic Lidocaine Gel n=53 participants at risk 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. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
Gastrointestinal disorders death	1.9% 1/53 • Number of events 53	1.9% 1/53 • Number of events 53

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ninel Gregori, MD

Miami Veterans Affairs Medical Center

Phone: 305-575-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place