Study on the Effect and Safety of Phenylephrine Hydrochloride, Tropicamide, and Lidocaine Hydrochloride in Children with Cataracts Undergoing Surgery

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What is this study about?

This clinical trial is focused on studying the effects and safety of a medication called Mydrane in children who are undergoing surgery for pediatric cataract. A cataract is a condition where the lens of the eye becomes cloudy, leading to vision problems. The treatment involves an injection of Mydrane directly into the eye during the surgery. Mydrane is a combination of three substances: phenylephrine hydrochloride, tropicamide, and lidocaine hydrochloride. These substances work together to help dilate the pupil, which is the opening in the center of the eye, and to provide local anesthesia, which numbs the area to prevent pain during the procedure.

The purpose of this study is to evaluate how effective and safe Mydrane is when used in children. During the study, children who are scheduled for cataract surgery will receive an injection of Mydrane. The study will monitor how well the pupil dilates, which is important for the surgery to be performed without needing additional mechanical dilation. Additionally, the study will observe any changes in heart rate and blood pressure to ensure the safety of the medication.

Participants in the study will be children aged 8 weeks to 17 years who are undergoing cataract surgery. The study aims to provide valuable information on the use of Mydrane in pediatric patients, helping to improve surgical outcomes and ensure the safety of young patients undergoing this procedure.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study is designed to evaluate the effectiveness and safety of an injection called Mydrane in children undergoing cataract surgery.

2 pre-surgery preparation

Before the surgery, you will undergo a series of assessments to ensure you meet the study criteria. This includes confirming your age, which should be between 8 weeks and 17 years, and that you are scheduled for cataract surgery.

3 administration of Mydrane

During the cataract surgery, an injection of Mydrane will be administered directly into the eye. This solution contains three active substances: phenylephrine hydrochloride, tropicamide, and lidocaine hydrochloride. These substances help in dilating the pupil and providing local anesthesia.

4 surgery

The surgery will proceed with the aim of repairing the cataract. The primary goal is to achieve sufficient pupil dilation to perform the surgery without needing additional mechanical dilation.

5 post-surgery monitoring

After the surgery, your heart rate and blood pressure will be monitored to assess any systemic side effects of the injection. This monitoring is part of the study’s secondary objectives.

6 follow-up

You will have follow-up appointments to evaluate the outcomes of the surgery and the effects of the Mydrane injection. These appointments are crucial for assessing the long-term safety and effectiveness of the treatment.

Who Can Join the Study?

Children aged 8 weeks to 17 years old.
Children who are scheduled for surgical repair of a cataract in one or both eyes. A cataract is a condition where the lens of the eye becomes cloudy, affecting vision.
Both boys and girls can participate.

Who Cannot Join the Study?

Where you can join this trial?

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Site Name	City	Country	Status
Uxgakkkbsb Ok Amvszgy	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	19.04.2023

Trial locations

Investigated drugs:

Mydrane is a medication used during eye surgeries, like cataract surgery, to help dilate the pupil. This means it makes the black part of the eye larger, which helps the surgeon see inside the eye better. In this trial, Mydrane is being tested to see how well it works and how safe it is for children who are having cataract surgery. The goal is to make sure that the surgery can be done more easily and safely with the help of this medication.

Investigated diseases:

Cataract

Pediatric Cataract – Pediatric cataract is a condition where the lens of a child’s eye becomes cloudy, leading to impaired vision. This cloudiness can occur in one or both eyes and may be present at birth or develop later in childhood. The progression of pediatric cataract can vary; in some cases, the cloudiness may remain stable, while in others, it can worsen over time. As the cataract progresses, it can interfere with the development of normal vision, potentially leading to amblyopia, also known as “lazy eye.” The condition can affect the child’s ability to see clearly, impacting their learning and development. Early detection and management are crucial to prevent long-term vision problems.

Trial ID:

2023-504173-21-00

Protocol code:

EDGE1169

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect and Safety of Phenylephrine Hydrochloride, Tropicamide, and Lidocaine Hydrochloride in Children with Cataracts Undergoing Surgery

What is this study about?

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