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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78374774
Enrollment
122
Registered
2009-07-09
Start date
2006-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract/topical anaesthesia Eye Diseases Other cataract

Interventions

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 (Xylo

Sponsors

University of Florida (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026