Condition category
Eye Diseases
Date applied
02/06/2009
Date assigned
09/07/2009
Last edited
18/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof K V Chalam

ORCID ID

Contact details

580 W 8th Street
Tower 2
3rd Floor
Jacksonville
32209
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparative efficacy of topical TetraVisc™ versus lidocaine gel in cataract surgery: randomised, multi-surgeon, controlled clinical trial

Acronym

Study hypothesis

To compare the clinical efficacy of lidocaine 2% gel with tetravisc drops for cataract surgery.

Ethics approval

Institutional Review Board/Ethics Committee of University of Florida (ref: 2007-007)

Study design

Randomised multi-surgeon controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cataract/topical anaesthesia

Intervention

The patients were randomised by block randomisation (randomly assigned by computer generated numbers) to receive either TetraVisc™ (Tetracaine hydrochloride 0.5%, OCuSOFT) eye drops or lidocaine (Xylocaine 2% jelly, Astra) consecutively. Five doses of TV or LG were applied every 5 minutes, 20 minutes prior to surgery. No intravenous or oral sedation was used as pre-medication.

Intervention type

Drug

Phase

Not Applicable

Drug names

TetraVisc™, lidocaine gel

Primary outcome measures

Grading intra-operative pain using a 0 to 10 Visual Analogue Scale (VAS) within 10 minutes of completion of surgery.

Secondary outcome measures

1. Grading the surgical experience as 0 - 10 where 0 is poor co-operation and 10 is excellent co-operation
2. Supplemental anaesthesia used
3. Intra-operative complications

Measured at the end of surgery.

Overall trial start date

01/01/2006

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing cataract surgery under topical anaesthesia
2. Aged 50 - 80 years, no gender preference

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

122

Participant exclusion criteria

1. Unwillingness to have topical anaesthesia
2. High anxiety
3. Dementia or mental instability
4. Deafness
5. Movement disorders
6. Hyperanxiety
7. Inability to complete the Visual Analogue Scale (VAS) of pain line (for example, confusion, communication barriers, visual impairment)
8. Any reported allergy to lidocaine or tetracaine

Recruitment start date

01/01/2006

Recruitment end date

30/11/2006

Locations

Countries of recruitment

United States of America

Trial participating centre

580 W 8th Street, Tower 2, 3rd Floor
Jacksonville
32209
United States of America

Sponsor information

Organisation

University of Florida (USA)

Sponsor details

Department of Ophthalmology
College of Medicine
580 W 8th Street
Tower 2
3rd Floor
Jacksonville
32209
United States of America

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Florida (USA) - Department of Ophthalmology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19686592

Publication citations

  1. Results

    Chalam KV, Murthy RK, Agarwal S, Gupta SK, Grover S, Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery., BMC Ophthalmol, 2009, 9, 7, doi: 10.1186/1471-2415-9-7.

Additional files

Editorial Notes