Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery - Full Text View

Sponsored by:	Hermann Eye Center
Information provided by:	Hermann Eye Center
ClinicalTrials.gov Identifier:	NCT00827073

Purpose

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	Intervention
Cataracts	Drug: betadine Drug: topical tetracaine Drug: lidocaine

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Safety Study
Official Title:	The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Cataract Surgery

Drug Information available for: Povidone-iodine Viractin Cadexomer iodine Tetracaine Lidocaine Proparacaine Proparacaine hydrochloride Iodine Povidone

U.S. FDA Resources

Further study details as provided by Hermann Eye Center:

Primary Outcome Measures:

Bacterial species and colony count [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Topical Anesthetic: Experimental	Drug: betadine betadine 5% Drug: topical tetracaine topical anesthetic
2 Anesthetic: Active Comparator	Drug: betadine betadine 5% Drug: lidocaine lidocaine 2% jelly

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%.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827073

Contacts

Contact: Joseph Selem, MD	713-559-5200	jselem@hotmail.com
Contact: Laura Baker	713-559-5263	laura.ann.baker@gmail.com

Locations

United States, Texas
Memorial Hermann Plaza Surgery Center	Recruiting
Houston, Texas, United States, 77030
Contact: Robert Lerma 713-790-7729 rlerma@uspi.com
Principal Investigator: Nan Wang, MD., PhD
Principal Investigator: Joseph Selem, MD
Sub-Investigator: Nicholas Bell, MD

Sponsors and Collaborators

Hermann Eye Center

Investigators

Principal Investigator:

Joseph Selem, MD

Robert Cizik Eye Clinic and Department of Ophthalmology and Visual Science at The University of Texas Medical School at Houston

More Information

Publications:

Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg. 1996 Jun;22(5):612-4.

Roman S, Auclin F, Ullern M. Topical versus peribulbar anesthesia in cataract surgery. J Cataract Refract Surg. 1996 Oct;22(8):1121-4.

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.

Bellucci R. Anesthesia for cataract surgery. Curr Opin Ophthalmol. 1999 Feb;10(1):36-41. Review.

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.

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.

Ciulla TA, Starr MB, Masket S. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology. 2002 Jan;109(1):13-24. Review.

Speaker MG, Menikoff JA. Prophylaxis of endophthalmitis with topical povidone-iodine. Ophthalmology. 1991 Dec;98(12):1769-75.

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.

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.

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.

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.

Responsible Party:	University of Texas at Houston Opthalmology Department ( Joseph Selem, MD )
Study ID Numbers:	HSC-MS-08-0454
Study First Received:	January 21, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00827073 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Infective Agents
Eye Diseases
Lidocaine
Anesthetics
Central Nervous System Depressants
Lens Diseases
Cardiovascular Agents
Povidone-Iodine
Proxymetacaine

Anesthetics, Local
Tetracaine
Anti-Infective Agents, Local
Cataract
Povidone
Iodine
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Eye Diseases
Physiological Effects of Drugs
Lidocaine
Anesthetics
Central Nervous System Depressants
Lens Diseases
Cardiovascular Agents
Povidone-Iodine
Anesthetics, Local

Pharmacologic Actions
Tetracaine
Anti-Infective Agents, Local
Sensory System Agents
Therapeutic Uses
Cataract
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009