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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05978687
Other study ID # 23149_Pterygium
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Vrije Universiteit Brussel
Contact Lennert Hellinckx, Master
Phone 0032 475397266
Email lennert.hellinckx@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OPHTESIC LIDOCAINE HYDROCHLORIDE 20MG/G
In group A, all patients will receive topical 2% lidocaine gel (ophtesic lidocaine hydrochloride 20 mg/G) prior to surgery. Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.
Xylocaine with Epinephrine
In group B, all patients will receive a subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine will be injected with a 27-gauge needle. When asked for, patients will receive additional topical 1% lidocaine eye drops. Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.

Locations

Country Name City State
Belgium UZ Brussel Brussel Brussels

Sponsors (1)

Lead Sponsor Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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

Outcome

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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