Comparative efficacy of topical TetraVisc™ versus lidocaine gel in cataract surgery

ISRCTN	ISRCTN78374774
DOI	https://doi.org/10.1186/ISRCTN78374774
Secondary identifying numbers	N/A

Submission date: 02/06/2009
Registration date: 09/07/2009
Last edited: 18/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof K V Chalam
Scientific

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

Study information

Study design	Randomised multi-surgeon controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparative efficacy of topical TetraVisc™ versus lidocaine gel in cataract surgery: randomised, multi-surgeon, controlled clinical trial
Study hypothesis	To compare the clinical efficacy of lidocaine 2% gel with tetravisc drops for cataract surgery.
Ethics approval(s)	Institutional Review Board/Ethics Committee of University of Florida (ref: 2007-007)
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	TetraVisc™, lidocaine gel
Primary outcome measure	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 study start date	01/01/2006
Overall study end date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	122
Participant inclusion criteria	1. Patients undergoing cataract surgery under topical anaesthesia 2. Aged 50 - 80 years, no gender preference
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

Study participating centre

580 W 8th Street, Tower 2, 3rd Floor

Jacksonville
32209
United States of America

Sponsor information

University of Florida (USA)
University/education

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

"ROR"	https://ror.org/02y3ad647

Funders

Funder type

University/education

University of Florida (USA) - Department of Ophthalmology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/08/2009		Yes	No