The Use of Lidocaine Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision

NCT05978687 | Completed Phase 4

• 1 other identifier: 23149_Pterygium
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pterygium

Keywords

Lidocaine gel; Pterygium; Dryness; Irritation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Secondary events

  Post-op day 8

• Change of OSDI score

  Post-op day 1 to 8

• Pain via Visual Analogue Pain Scale at administration of anesthesia

  Per-operative at administration of anesthesia

• Pain via Visual Analogue Pain Scale at incision

  Per-operative at incision

• Pain via Visual Analogue Pain Scale < 5 minutes after the operation

  <5 minutes after operation

Study Arms (2)

Topical lidocaine gel

EXPERIMENTAL

All patients will receive topical 2% lidocaine gel (Ophtesic lidocaine gel) prior to surgery

Drug: OPHTESIC LIDOCAINE HYDROCHLORIDE 20MG/G

Subconjunctival xylocaine injection

ACTIVE COMPARATOR

All patients will receive a subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine will be injected with a 27-gauge needle

Drug: Xylocaine with Epinephrine

Interventions

Xylocaine with Epinephrine DRUG

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.

Also known as: Subconjucntival injection with xylocain injection

Subconjunctival xylocaine injection

OPHTESIC LIDOCAINE HYDROCHLORIDE 20MG/G DRUG

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.

Also known as: Lidocain gel

Topical lidocaine gel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication of pterygium excision

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Related 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.

  PMID: 15799734 BACKGROUND

MeSH Terms

Conditions

Pterygium

Interventions

Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Karolien Termote, Master

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 7, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)