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

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What is this study about?

This clinical trial is focused on studying the effectiveness of different anesthetic treatments for patients with glaucoma, a condition that affects the eyes and can lead to vision loss. The study involves patients who have undergone surgery for glaucoma and require a procedure known as needling, which is performed in an outpatient setting. The trial compares two types of anesthetic treatments: a gel containing 2% lidocaine, which is applied to the eye, and eye drops containing a combination of tetracaine and oxybuprocaine.

The purpose of the study is to determine which anesthetic treatment is more effective in reducing pain during the needling procedure. Participants will receive either the lidocaine gel or the tetracaine/oxybuprocaine eye drops before their procedure. The study will measure the level of pain experienced by patients using a simple numerical scale, as well as the time taken to complete the procedure with each type of anesthetic. Additionally, the study will observe if any patients require additional anesthesia or oral pain relief, and assess the comfort of the surgeon and the patient’s cooperation during the procedure.

This trial aims to provide valuable information on the best anesthetic approach for patients undergoing needling procedures after glaucoma surgery. By comparing the two treatments, the study seeks to improve patient comfort and surgical outcomes in glaucoma care. The trial is expected to conclude by June 2024, with recruitment starting in November 2023.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes being over 18 years of age, having undergone glaucoma surgery, and requiring a needling procedure.

Informed consent is signed, indicating understanding and agreement to participate.

2 preparation for procedure

Before the procedure, the assigned anesthetic is prepared. This will be either 2% lidocaine gel or tetracaine/oxybuprocaine eye drops.

The anesthetic is applied to the eye to ensure comfort during the needling procedure.

3 needling procedure

The needling procedure is performed as part of the glaucoma surgery follow-up.

The main objective is to assess the anesthetic efficacy by measuring pain levels using a numerical rating scale from 0 to 10.

4 post-procedure assessment

After the procedure, the time taken for the procedure is recorded.

Pain levels are assessed again using the numerical rating scale.

The need for additional anesthesia or oral pain relief is evaluated.

5 surgeon and patient feedback

Feedback is collected regarding the surgeon’s comfort and the patient’s cooperation during the procedure.

The visualization of the surgical field is assessed using a scale from 0 to 5, with 5 being the best possible visualization.

6 follow-up

Follow-up visits may be scheduled to monitor recovery and any potential side effects.

The study aims to conclude by June 29, 2024, with recruitment starting on November 15, 2023.

Who Can Join the Study?

Patients who have had surgery for glaucoma and need a procedure called needling.
Patients who are over 18 years old.
Patients who have read, understood, and signed a form agreeing to participate in the study.
Both men and women can participate.

Who Cannot Join the Study?

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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Trial status

Country	Status	Recruitment Start
Spain	Recruiting	15.11.2023

Trial locations

Investigated drugs:

Lidocaine Gel is used as a local anesthetic to numb the surface of the eye. In this clinical trial, it is being tested for its effectiveness in providing pain relief during outpatient glaucoma surgery procedures.

Tetracaine Eye Drops are another type of local anesthetic used to numb the eye. These drops are being compared to lidocaine gel in the trial to see which provides better pain relief during the surgical procedure.

Oxybuprocaine Eye Drops are also used as a local anesthetic for numbing the eye. In this study, they are combined with tetracaine to evaluate their effectiveness in reducing pain during glaucoma surgery.

Investigated diseases:

Glaucoma

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, which is vital for good vision. This damage is often caused by an 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 is typically slow, and it may not show symptoms until significant damage has occurred. Regular eye exams are crucial for early detection, as early stages might not present noticeable symptoms. The disease can affect one or both eyes and is more common in older adults.

Trial ID:

2023-505802-40-02

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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