Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery

• Sponsor: Hermann Eye Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00827073
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 19.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if there is a difference on the penetration of betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract surgery. This will be assessed comparing bacterial colony count and species by taking swabs from the eye surface before and after the topical anesthesia has been administered.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Drug: tetracaine 0.5%; Drug: Lidocaine 2% Jelly	N/A

Detailed Description

The purpose of this research study is to show that using Lidocaine2% jelly before surgery as an anesthetic (keep you from feeling touch or pain) for cataract surgery does not block the antiseptic (cleans and kills germs) effect of Betadine5%.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tetracaine 0.5% drop Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered	Drug: tetracaine 0.5%; betadine 5%
Active Comparator: Lidocaine 2% Jelly Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered	Drug: Lidocaine 2% Jelly; Betadine 5%

Outcome Measures

Primary Outcome Measures

1. Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs [(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)]

   Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.

2. Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs [(1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• greater or equal to 18 years old

• uni- or bi-lateral visually significant cataracts

Exclusion Criteria:

• hypersensitivity to betadine5%, topical tetracaine0.5%, or lidocaine2% jelly

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Hermann Plaza Surgery Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Hermann Eye Center

Investigators

• Principal Investigator: Nan Wang, MD, Robert Cizik Eye Clinic and Department of Ophthalmology and Visual Science at The University of Texas Medical School at Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

• Amiel H, Koch PS. Tetracaine hydrochloride 0.5% versus lidocaine 2% jelly as a topical anesthetic agent in cataract surgery: comparative clinical trial. J Cataract Refract Surg. 2007 Jan;33(1):98-100.
• Bellucci R. Anesthesia for cataract surgery. Curr Opin Ophthalmol. 1999 Feb;10(1):36-41. Review.
• Ciulla TA, Starr MB, Masket S. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology. 2002 Jan;109(1):13-24. Review.
• Deramo VA, Lai JC, Fastenberg DM, Udell IJ. Acute endophthalmitis in eyes treated prophylactically with gatifloxacin and moxifloxacin. Am J Ophthalmol. 2006 Nov;142(5):721-5. Epub 2006 Sep 20.
• Ferguson AW, Scott JA, McGavigan J, Elton RA, McLean J, Schmidt U, Kelkar R, Dhillon B. Comparison of 5% povidone-iodine solution against 1% povidone-iodine solution in preoperative cataract surgery antisepsis: a prospective randomised double blind study. Br J Ophthalmol. 2003 Feb;87(2):163-7.
• Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg. 1996 Jun;22(5):612-4.
• Leong JK, Shah R, McCluskey PJ, Benn RA, Taylor RF. Bacterial contamination of the anterior chamber during phacoemulsification cataract surgery. J Cataract Refract Surg. 2002 May;28(5):826-33.
• Maclean H, Burton T, Murray A. Patient comfort during cataract surgery with modified topical and peribulbar anesthesia. J Cataract Refract Surg. 1997 Mar;23(2):277-83.
• Patel BC, Clinch TE, Burns TA, Shomaker ST, Jessen R, Crandall AS. Prospective evaluation of topical versus retrobulbar anesthesia: a converting surgeon's experience. J Cataract Refract Surg. 1998 Jun;24(6):853-60.
• Roman S, Auclin F, Ullern M. Topical versus peribulbar anesthesia in cataract surgery. J Cataract Refract Surg. 1996 Oct;22(8):1121-4.
• Seal DV, Barry P, Gettinby G, Lees F, Peterson M, Revie CW, Wilhelmus KR; ESCRS Endophthalmitis Study Group. ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Case for a European multicenter study. J Cataract Refract Surg. 2006 Mar;32(3):396-406. Erratum in: J Cataract Refract Surg. 2006 May;32(5):709.
• Speaker MG, Menikoff JA. Prophylaxis of endophthalmitis with topical povidone-iodine. Ophthalmology. 1991 Dec;98(12):1769-75.
• Virtanen P, Huha T. Pain in scleral pocket incision cataract surgery using topical and peribulbar anesthesia. J Cataract Refract Surg. 1998 Dec;24(12):1609-13.

• Responsible Party: Joseph Selem, Principle Investigator, Hermann Eye Center
• ClinicalTrials.gov Identifier: NCT00827073
• Other Study ID Numbers: HSC-MS-08-0454
• First Posted: Jan 22, 2009
• Last Update Posted: Jul 22, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Cataract; Lidocaine; Tetracaine

Study Results

Participant Flow

Arm/Group Title	Tetracaine 5% Drop	Lidocaine 2% Jelly
Arm/Group Description	betadine: betadine 5%, topical anesthetic drop	betadine: betadine 5% Anesthetic: lidocaine 2% jelly
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Tetracaine 5% Drop	Lidocaine 2% Jelly	Total
Arm/Group Description	betadine: betadine 5% topical anesthetic	betadine: betadine 5% anesthetic	Total of all reporting groups
Overall Participants	20	20	40
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	70.0 (7.4)	68.4 (11.8)	69.2 (9.8)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 30%	8 40%	14 35%
>=65 years	14 70%	12 60%	26 65%
Sex: Female, Male (Count of Participants)
Female	13 65%	14 70%	27 67.5%
Male	7 35%	6 30%	13 32.5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs
Description	Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.
Time Frame	(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine 0.5% Drop	Lidocaine 2% Jelly
Arm/Group Description	betadine: betadine 5% topical anesthetic	betadine: betadine 5% Anesthetic
Measure Participants	20	20
Mean (Standard Deviation) [Ln(bacterial colony count)]	-0.14 (0.67)	-0.52 (1.85)

2. Primary Outcome

Title	Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs
Time Frame	(1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine 0.5% Drop	Lidocaine 2% Jelly
Arm/Group Description	betadine: betadine 5% topical anesthetic	betadine: betadine 5% Anesthetic
Measure Participants	20	20
pre number of bacterial spices	1 (0)	1 (0)
post surgery number of bacterial speices	1 (0)	1 (0)

Adverse Events

Arm/Group Title	Tetracaine 0.5% Drop		Lidocaine 2% Jelly
Arm/Group Description	betadine: betadine 5% Topical Anesthetic		betadine: betadine 5% Anesthetic
All Cause Mortality
	Tetracaine 0.5% Drop		Lidocaine 2% Jelly
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tetracaine 0.5% Drop		Lidocaine 2% Jelly
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Tetracaine 0.5% Drop		Lidocaine 2% Jelly
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.