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Study Comparing Lidocaine Gel and Tetracaine/Oxybuprocaine Eye Drops for Anesthesia in Glaucoma Patients Undergoing Needling Procedures

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and patient satisfaction of two different anesthetic treatments used during eye procedures for patients with glaucoma. Glaucoma is a condition that affects the eyes and can lead to vision loss if not treated properly. The study compares a 2% gel containing lidocaine, which is applied to the eye, with tetracaine and oxybuprocaine eye drops, which are used as a solution. These treatments are intended to numb the eye during procedures that are necessary for managing glaucoma.

The purpose of the study is to determine which anesthetic method provides better pain relief and overall satisfaction for patients undergoing these eye procedures. Participants will receive either the lidocaine gel or the tetracaine/oxybuprocaine eye drops before their procedure. The study will monitor the level of pain experienced by patients, as well as the comfort of the surgeon performing the procedure. Additionally, the study will observe any side effects or complications that may occur during or after the procedure.

Throughout the study, researchers will collect information on various factors, such as the number of additional anesthetic drops needed, the condition of the eye's surface, and the pressure inside the eye, known as intraocular pressure. The study aims to provide valuable insights into which anesthetic method is more effective and satisfactory for patients with glaucoma undergoing these specific eye procedures.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Eligibility is confirmed for patients who have undergone glaucoma surgery and require a needling procedure. Participants must be over 18 years old and have signed the informed consent.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather demographic information such as age and sex. Baseline measurements of intraocular pressure (IOP) are taken using Goldmann applanation tonometry.

  3. Step 3

    Administration of anesthetic

    Participants receive either 2% lidocaine gel or tetracaine/oxybuprocaine eye drops as anesthesia for the needling procedure. The lidocaine gel is applied as an eye gel, while the tetracaine/oxybuprocaine is administered as eye drops.

  4. Step 4

    Needling procedure

    The needling procedure is performed in the ophthalmology consultation. The effectiveness of the anesthesia is evaluated using a numerical rating scale (NRS) from 0 to 10 for pain and surgeon comfort.

  5. Step 5

    Post-procedure assessment

    Post-procedure assessments include the number of tetracaine booster drops used, the need for oral pain relief, and the condition of the ocular surface measured by the Oxford Scale from 0 to 5.

  6. Step 6

    Follow-up

    Follow-up includes monitoring for any complications during and after the needling procedure. Intraocular pressure is measured again, and the success of the procedure is evaluated at 3 months, considering both absolute and relative success rates.

Who can join the trial?

4 criteria

  • Patients who have had surgery for glaucoma and need a procedure called needling during a consultation.
  • Must be over 18 years old.
  • Must understand and sign a document called informed consent, which explains the study and confirms their agreement to participate.
  • Both men and women can participate.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with glaucoma cannot participate. Glaucoma is a condition that affects the eyes and can lead to vision loss.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

  • Lidocaine Gel

    is a topical anesthetic used in this trial to numb the surface of the eye. It is applied as a gel and works by blocking nerve signals in the area where it is applied, providing pain relief during ophthalmic procedures.

  • Tetracaine/Oxybuprocaine Eye Drops

    are a combination of two anesthetic agents used to numb the eye. These drops are applied directly to the eye and work by temporarily blocking the nerve signals, helping to reduce pain and discomfort during eye procedures.

What is already known about the treatment

  • Lidocaine

    Lidocaine is administered as a 2% gel applied directly to the eye for local anesthesia. It is widely used in medical practice and literature for its effectiveness in providing local anesthesia during minor surgical procedures. The main therapeutic indication for lidocaine in this context is to numb the eye during ophthalmic procedures. At the molecular level, lidocaine works by blocking sodium channels, which prevents the initiation and conduction of nerve impulses, leading to a loss of sensation in the targeted area. It is classified as a local anesthetic.

  • Tetracaine/Oxybuprocaine

    This medication is administered as eye drops, combining tetracaine hydrochloride and oxybuprocaine hydrochloride, to provide local anesthesia for ophthalmic procedures. It is recognized in medical literature for its use in numbing the eye to facilitate various eye treatments. The main therapeutic indication is to provide anesthesia during procedures such as needling in ophthalmology. The mechanism of action involves blocking sodium channels in nerve cells, which inhibits nerve impulse transmission and results in temporary loss of sensation. It is classified as a local anesthetic.

Investigated diseases

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, which is crucial for good vision. This damage is often caused by abnormally high pressure in the eye. Over time, increased pressure can erode the optic nerve tissue, which may lead to vision loss or even blindness if not managed. The progression of glaucoma can vary, with some people experiencing a slow loss of vision, while others may notice a more rapid decline. It is often asymptomatic in the early stages, making regular eye exams important for early detection. As the disease advances, individuals may notice blind spots in their peripheral vision.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505131-13-01Protocol codeANELI 003Estimated enrolment60 patientsSponsorHospital Del Mar

sourced from the EU Clinical Trials Register and site verification

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