Comparative efficacy of topical TetraVisc™ versus lidocaine gel in cataract surgery
| ISRCTN | ISRCTN78374774 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78374774 |
| Protocol serial number | N/A |
| Sponsor | University of Florida (USA) |
| Funder | University of Florida (USA) - Department of Ophthalmology |
- 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 of protocol
Not provided at time of registration
Contact information
Prof K V Chalam
Scientific
Scientific
580 W 8th Street, Tower 2, 3rd Floor
Jacksonville
32209
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised multi-surgeon controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparative efficacy of topical TetraVisc™ versus lidocaine gel in cataract surgery: randomised, multi-surgeon, controlled clinical trial |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | TetraVisc™, lidocaine gel |
| Primary outcome measure(s) |
Grading intra-operative pain using a 0 to 10 Visual Analogue Scale (VAS) within 10 minutes of completion of surgery. |
| Key secondary outcome measure(s) |
1. Grading the surgical experience as 0 - 10 where 0 is poor co-operation and 10 is excellent co-operation |
| Completion date | 30/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 122 |
| Key inclusion criteria | 1. Patients undergoing cataract surgery under topical anaesthesia 2. Aged 50 - 80 years, no gender preference |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 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
32209
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
