NCT00827073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

June 23, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1.7 years

First QC Date

January 21, 2009

Results QC Date

March 11, 2014

Last Update Submit

July 11, 2014

Conditions

Cataracts

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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)

Study Arms (2)

Tetracaine 0.5% drop

ACTIVE COMPARATOR

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

Drug: tetracaine 0.5%

Lidocaine 2% Jelly

ACTIVE COMPARATOR

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

Drug: Lidocaine 2% Jelly

Interventions

tetracaine 0.5%DRUG

betadine 5%

Tetracaine 0.5% drop
Lidocaine 2% JellyDRUG

Betadine 5%

Lidocaine 2% Jelly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • greater or equal to 18 years old
  • uni- or bi-lateral visually significant cataracts

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Plaza Surgery Center

Houston, Texas, 77030, United States

Location

Related Publications (13)

  • 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.

    PMID: 8784636BACKGROUND

  • 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.

    PMID: 8915811BACKGROUND

  • 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.

    PMID: 9850899BACKGROUND

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

    PMID: 10387317BACKGROUND

  • 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.

    PMID: 17189801BACKGROUND

  • 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.

    PMID: 11978463BACKGROUND

  • 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.

    PMID: 11772573BACKGROUND

  • 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.

    PMID: 1775308BACKGROUND

  • 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.

    PMID: 16989762BACKGROUND

  • 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.

    PMID: 9113582BACKGROUND

  • 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.

    PMID: 9642600BACKGROUND

  • 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.

    PMID: 16631046BACKGROUND

  • 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.

    PMID: 12543744BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

LidocaineGels

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Joseph Selem, MD
Organization
Robert Cizik Eye Clinic
laurabaker@cizikeye.org
713-559-5263

Study Officials

  • Nan Wang, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 22, 2014

Results First Posted

June 23, 2014

Record last verified: 2014-07

Locations

US(1)