Pterygium Clinical Trial
— LIDPTEROfficial title:
The Use of Lidocaine Ophtesic Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision
In pterygium excision procedures, the subconjunctival injection of xylocain is regarded as an uncomfortable and painful step in the procedure. While already being studied in other ophthalmic procedures such as glaucoma surgery (7), application of topical lidocaine gel is likely to minimize pain. The gel has a longer surface contact time due to its consistency, providing not only a longer anesthetic effect, but protecting the corneal surface against desiccation, when compared to eye drops. The investigators hypothesize that Ophtesic 2% lidocaine gel is as effective as an anesthetic in pterygium excision as subconjunctival injection, while providing more comfort during surgery and less corneal dryness afterwards. Our goal is to compare both the anesthetic and corneal surface effect of topical 2% lidocaine gel to subconjunctival injection of xylocaine 2% solution with 0.125 epinephrine in pterygium surgery: - Compare the patients pain during and after surgery - Compare corneal dryness after surgery. - Evaluate possible secondary events
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Brussel | Brussels |
Lead Sponsor | Collaborator |
---|---|
Vrije Universiteit Brussel |
Belgium,
Oksuz H, Tamer C. Efficacy of lidocaine 2% gel in pterygium surgery. Acta Ophthalmol Scand. 2005 Apr;83(2):206-9. doi: 10.1111/j.1600-0420.2005.00404.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in OSDI score POD8 | The Ocular Surface Disease Index OSDI (12) is a subjective manner of assessing dryness. The questionnaire will be available in English, Dutch and French. Our primary outcome is the difference in OSDI score between both groups after 8 days. | Post-op day 8 | |
Secondary | Secondary events | Number of secondary events in absolute numbers (non-adherence of graft, endophtalmitis, ...) | Post-op day 8 | |
Secondary | Change of OSDI score | The Ocular Surface Disease Index OSDI (12) is a subjective manner of assessing dryness. The questionnaire will be available in English, Dutch and French. A secondary outcome is the mean difference of the OSDI score between both groups. | Post-op day 1 to 8 | |
Secondary | Pain via Visual Analogue Pain Scale at administration of anesthesia | We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable). | Per-operative at administration of anesthesia | |
Secondary | Pain via Visual Analogue Pain Scale at incision | We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable). | Per-operative at incision | |
Secondary | Pain via Visual Analogue Pain Scale < 5 minutes after the operation | We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable). | <5 minutes after operation | |
Secondary | Pain via Visual Analogue Pain Scale 1 day after the operation | We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable). | Post-op day 1 | |
Secondary | Pain via Visual Analogue Pain Scale 8 days after the operation | We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable). | Post-op day 8 | |
Secondary | Change in pain via Visual Analogue Pain Scale | We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable). | pre-operative, post-op day 1 and day 8 |
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