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

NCT ID: NCT00827073

Last Updated: 2014-07-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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%.

Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tetracaine 0.5% drop

Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered

Group Type ACTIVE_COMPARATOR

tetracaine 0.5%

Intervention Type DRUG

betadine 5%

Lidocaine 2% Jelly

Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered

Group Type ACTIVE_COMPARATOR

Lidocaine 2% Jelly

Intervention Type DRUG

Betadine 5%

Interventions

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tetracaine 0.5%

betadine 5%

Intervention Type DRUG

Lidocaine 2% Jelly

Betadine 5%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hermann Eye Center

OTHER

Sponsor Role lead

Responsible Party

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Joseph Selem

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Memorial Hermann Plaza Surgery Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg. 1996 Jun;22(5):612-4. doi: 10.1016/s0886-3350(96)80019-8.

Reference Type BACKGROUND
PMID: 8784636 (View on PubMed)

Roman S, Auclin F, Ullern M. Topical versus peribulbar anesthesia in cataract surgery. J Cataract Refract Surg. 1996 Oct;22(8):1121-4. doi: 10.1016/s0886-3350(96)80129-5.

Reference Type BACKGROUND
PMID: 8915811 (View on PubMed)

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. doi: 10.1016/s0886-3350(98)80351-9.

Reference Type BACKGROUND
PMID: 9850899 (View on PubMed)

Bellucci R. Anesthesia for cataract surgery. Curr Opin Ophthalmol. 1999 Feb;10(1):36-41. doi: 10.1097/00055735-199902000-00007.

Reference Type BACKGROUND
PMID: 10387317 (View on PubMed)

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. doi: 10.1016/j.jcrs.2006.09.013.

Reference Type BACKGROUND
PMID: 17189801 (View on PubMed)

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. doi: 10.1016/s0886-3350(01)01160-9.

Reference Type BACKGROUND
PMID: 11978463 (View on PubMed)

Ciulla TA, Starr MB, Masket S. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology. 2002 Jan;109(1):13-24. doi: 10.1016/s0161-6420(01)00899-5.

Reference Type BACKGROUND
PMID: 11772573 (View on PubMed)

Speaker MG, Menikoff JA. Prophylaxis of endophthalmitis with topical povidone-iodine. Ophthalmology. 1991 Dec;98(12):1769-75. doi: 10.1016/s0161-6420(91)32052-9.

Reference Type BACKGROUND
PMID: 1775308 (View on PubMed)

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. doi: 10.1016/j.ajo.2006.05.044. Epub 2006 Sep 20.

Reference Type BACKGROUND
PMID: 16989762 (View on PubMed)

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. doi: 10.1016/s0886-3350(97)80354-9.

Reference Type BACKGROUND
PMID: 9113582 (View on PubMed)

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. doi: 10.1016/s0886-3350(98)80143-0.

Reference Type BACKGROUND
PMID: 9642600 (View on PubMed)

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. doi: 10.1016/j.jcrs.2006.02.014.

Reference Type BACKGROUND
PMID: 16631046 (View on PubMed)

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. doi: 10.1136/bjo.87.2.163.

Reference Type BACKGROUND
PMID: 12543744 (View on PubMed)

Other Identifiers

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HSC-MS-08-0454

Identifier Type: -

Identifier Source: org_study_id

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