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

Overview

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.

Full Title of Study: “The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2010

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%.

Interventions

  • Drug: tetracaine 0.5%
    • betadine 5%
  • Drug: Lidocaine 2% Jelly
    • Betadine 5%

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs
    • Time Frame: (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.
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hermann Eye Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joseph Selem, Principle Investigator – Hermann Eye Center
  • Overall Official(s)
    • Nan Wang, MD, Principal Investigator, Robert Cizik Eye Clinic and Department of Ophthalmology and Visual Science at The University of Texas Medical School at Houston

References

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.