Comparing Lidocaine Gel and Xylocaine Injection for Pterygium Surgery
The Use of Lidocaine Ophtesic Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision
PHASE4 · Vrije Universiteit Brussel · NCT05978687
This study is testing whether a lidocaine gel can provide the same pain relief as an injection during pterygium surgery while making recovery more comfortable for patients.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Brussel, Brussels) |
| Trial ID | NCT05978687 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and comfort of 2% lidocaine gel versus subconjunctival injection of xylocaine during pterygium excision procedures. The study hypothesizes that the topical gel will provide similar anesthetic effects while reducing pain and corneal dryness post-surgery. Participants will be monitored for pain levels during and after the procedure, as well as for any corneal surface effects. The trial is being conducted at UZ Brussel, led by Vrije Universiteit Brussel.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for pterygium excision who do not have a history of autoimmune diseases or previous pterygium surgery.
Not a fit: Patients with autoimmune diseases, anxiety disorders, or those who have previously undergone pterygium excision may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a more comfortable surgical experience and improved recovery for patients undergoing pterygium excision.
How similar studies have performed: Previous studies have shown success with lidocaine gel in other ophthalmic procedures, suggesting potential for similar outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication of pterygium excision Exclusion Criteria: * No history of auto-immune diseases such as Sjögren, Lupus, Graves, Graft-versus-host disease, rheumatoid artritis * No history of deafness, anxiety disorders, communicative barrier, impossibility to comprehend the Visual Analogue Pain Scale or the OSDI questionnaire. * Patient who already had pterygium excision
Where this trial is running
Brussel, Brussels
- UZ Brussel — Brussel, Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Karolien Termote, Master — Vrije Universiteit Brussel
- Study coordinator: Lennert Hellinckx, Master
- Email: lennert.hellinckx@uzbrussel.be
- Phone: 0032 475397266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pterygium, Lidocaine gel, Dryness, Irritation