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

NCT01087489 | Completed Results

• 1 other identifier: 00825
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

pain; discomfort; anesthetic drugs; topical drug administration; injections, intraocular; lidocaine; intraocular pressure; keratopathy

Outcome Measures

Primary Outcomes (1)

• Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection

  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

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

Secondary Outcomes (2)

• Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg

  immediately after injection, at 5, 10, 15 minutes

• Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage

  within 10 minutes of the injection

Study Arms (2)

4% lidocaine

EXPERIMENTAL

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

3.5% ophthalmic lidocaine gel

EXPERIMENTAL

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

Interventions

4% lidocaine DRUG

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.

Also known as: lidocaine

4% lidocaine

3.5% ophthalmic lidocaine gel DRUG

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.

Also known as: Akten

3.5% ophthalmic lidocaine gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment
• Informed consent
• Age ≥ 18 years
• Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication
• Able to understand and read English

You may not qualify if:

• Pregnancy (positive pregnancy test)
• Mental disability
• Prisoners
• Patients with fluctuating or impaired decision-making capacity
• Inability to comply with study or follow-up procedures
• Previous reaction to the same drug class

Sponsors & Collaborators

• Miami VA Healthcare System: lead
• University of Miami: collaborator
• Bascom Palmer Eye Institute: collaborator

Study Sites (1)

Miami Veterans Affairs Medical Center

Miami, Florida, 33125, United States

Location

Related Publications (11)

• Friedman SM, Margo CE. Topical gel vs subconjunctival lidocaine for intravitreous injection: a randomized clinical trial. Am J Ophthalmol. 2006 Nov;142(5):887-8. doi: 10.1016/j.ajo.2006.06.033.

  PMID: 17056383 BACKGROUND

• Caudle LE, Williams KA, Pesudovs K. The Eye Sensation Scale: an ophthalmic pain severity measure. Optom Vis Sci. 2007 Aug;84(8):752-62. doi: 10.1097/OPX.0b013e31812f7690.

  PMID: 17700338 BACKGROUND

• Chalam KV, Murthy RK, Agarwal S, Gupta SK, Grover S. Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery. BMC Ophthalmol. 2009 Aug 17;9:7. doi: 10.1186/1471-2415-9-7.

  PMID: 19686592 BACKGROUND

• Busbee BG, Alam A, Reichel E. Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study. Ophthalmic Surg Lasers Imaging. 2008 Sep-Oct;39(5):386-90. doi: 10.3928/15428877-20080901-03.

  PMID: 18831420 BACKGROUND

• Page MA, Fraunfelder FW. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601-9. doi: 10.2147/opth.s4935. Epub 2009 Nov 2.

  PMID: 19898665 BACKGROUND

• Soliman MM, Macky TA, Samir MK. Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops. J Cataract Refract Surg. 2004 Aug;30(8):1716-20. doi: 10.1016/j.jcrs.2003.12.034.

  PMID: 15313296 BACKGROUND

• Bardocci A, Lofoco G, Perdicaro S, Ciucci F, Manna L. Lidocaine 2% gel versus lidocaine 4% unpreserved drops for topical anesthesia in cataract surgery: a randomized controlled trial. Ophthalmology. 2003 Jan;110(1):144-9. doi: 10.1016/s0161-6420(02)01562-2.

  PMID: 12511360 BACKGROUND

• Cintra LP, Lucena LR, Da Silva JA, Costa RA, Scott IU, Jorge R. Comparative study of analgesic effectiveness using three different anesthetic techniques for intravitreal injection of bevacizumab. Ophthalmic Surg Lasers Imaging. 2009 Jan-Feb;40(1):13-8. doi: 10.3928/15428877-20090101-05.

  PMID: 19205490 BACKGROUND

• Kozak I, Cheng L, Freeman WR. Lidocaine gel anesthesia for intravitreal drug administration. Retina. 2005 Dec;25(8):994-8. doi: 10.1097/00006982-200512000-00007.

  PMID: 16340529 BACKGROUND

• Gregori NZ, Weiss MJ, Goldhardt R, Schiffman JC, Vega E, Mattis CA, Shi W, Kelley L, Hernandez V, Feuer WJ. Ocular decompression with cotton swabs lowers intraocular pressure elevation after intravitreal injection. J Glaucoma. 2014 Oct-Nov;23(8):508-12. doi: 10.1097/IJG.0b013e318294865c.

  PMID: 23632408 DERIVED

• Gregori NZ, Weiss MJ, Goldhardt R, Schiffman JC, Vega E, Mattis CA, Shi W, Kelley L, Hernandez V, Feuer WJ. Randomized clinical trial of two anesthetic techniques for intravitreal injections: 4% liquid lidocaine on cotton swabs versus 3.5% lidocaine gel. Expert Opin Drug Deliv. 2012 Jul;9(7):735-41. doi: 10.1517/17425247.2012.685155. Epub 2012 May 3.

  PMID: 22554019 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

discomfort One hour after injection was assessed the next day via telephone and might be affected by recall bias.

Results Point of Contact

• Title: Dr. Ninel Gregori, MD
• Organization: Miami Veterans Affairs Medical Center

ngregori@med.miami.edu

305-575-7000

Study Officials

• Ninel Gregori, MD

  Miami VA Healthcare Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: April 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 20, 2012
• Results First Posted: November 20, 2012

Record last verified: 2012-11

Locations

US (1)