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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Del Mar	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	30.09.2023

Trial locations

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.

Investigated diseases:

Glaucoma

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 ID:

2023-505131-13-01

Protocol code:

ANELI 003

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?