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

Primary Purpose

Cataracts

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

tetracaine 0.5%

Lidocaine 2% Jelly

About this trial

This is an interventional supportive care trial for Cataracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Memorial Hermann Plaza Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tetracaine 0.5% drop

Lidocaine 2% Jelly

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs

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.

Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs

Secondary Outcome Measures

Full Information

NCT ID

NCT00827073

First Posted

January 21, 2009

Last Updated

July 11, 2014

Sponsor

Hermann Eye Center

1. Study Identification

Unique Protocol Identification Number

NCT00827073

Brief Title

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

Official Title

The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hermann Eye Center

4. Oversight

Data Monitoring Committee

5. 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.

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataracts

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tetracaine 0.5% drop

Arm Type

Active Comparator

Arm Description

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

Arm Title

Lidocaine 2% Jelly

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

tetracaine 0.5%

Intervention Description

betadine 5%

Intervention Type

Drug

Intervention Name(s)

Lidocaine 2% Jelly

Intervention Description

Betadine 5%

Primary Outcome Measure Information:

Title

Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs

Description

Time Frame

(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nan Wang, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Hermann Plaza Surgery Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8784636

Citation

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.

Results Reference

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PubMed Identifier

8915811

Citation

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.

Results Reference

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PubMed Identifier

9850899

Citation

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.

Results Reference

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PubMed Identifier

10387317

Citation

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

Results Reference

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PubMed Identifier

17189801

Citation

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.

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PubMed Identifier

11978463

Citation

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.

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PubMed Identifier

11772573

Citation

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.

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PubMed Identifier

1775308

Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

9113582

Citation

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.

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PubMed Identifier

9642600

Citation

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.

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PubMed Identifier

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Citation

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. Erratum In: J Cataract Refract Surg. 2006 May;32(5):709.

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PubMed Identifier

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Citation

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

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