Ongoing Clinical Trials for Cataract
Currently, there are 3 ongoing clinical trials investigating new treatment approaches for patients undergoing cataract surgery. These studies focus on reducing inflammation after surgery and improving surgical procedures, with trials being conducted in Belgium and Norway.
Clinical trial locations
- Belgium
- Norway
Comparison of preservative-free versus preserved dexamethasone and diclofenac eye drops in patients after cataract surgery
This trial is comparing two types of eye drops used after cataract surgery to determine which works better for managing inflammation and promoting healing. The study involves patients who have recently undergone surgery to remove a cloudy lens from their eye.
Who can participate: You may be eligible if you are 60 years of age or older and have been diagnosed with age-related cataract. Both men and women can join the study. You must be able to undergo cataract surgery and be willing to use eye drops as prescribed. You should be mentally capable of understanding the study and providing your consent to participate.
Who cannot participate: You cannot join this study if you are under 18 years old, have known allergies to any components in the eye drops, have current eye infections or active inflammation, or have had previous eye surgery within the last 6 months. Other exclusion factors include the presence of serious eye conditions besides cataract, pregnancy or breastfeeding, participation in another clinical trial within the last 30 days, severe dry eye syndrome, use of contact lenses, uncontrolled glaucoma (increased eye pressure), history of complicated cataract surgery, mental conditions affecting informed consent, or severe systemic diseases.
What the trial involves: The study focuses on determining whether preservative-free eye drops are more effective than preserved eye drops for post-surgery care. Participants will receive treatment for 4 weeks after their cataract surgery. Throughout the study, various aspects of eye health will be measured, including tear production, eye surface condition, and inflammation levels. Both treatment groups use the same active medications, with the only difference being the presence or absence of preservatives.
Investigational drugs: Two medications are being tested in this trial. Dexamethasone is an anti-inflammatory steroid eye drop that reduces inflammation, swelling, redness, and irritation after surgery. Diclofenac is a non-steroidal anti-inflammatory medication that helps reduce pain and inflammation. Both medications are available in preservative-free forms (Monofree Dexamethason and Dicloabak) and preserved forms (Maxidex and Voltaren Ophtha). Preservative-free eye drops are generally gentler on the eye’s surface and may be better tolerated by some patients.
Study on Reducing Inflammation After Cataract Surgery Using Nepafenac and Dexamethasone for Patients Undergoing Surgery
This trial investigates how different medication regimens can help manage inflammation inside the eye after cataract surgery. Inflammation is the body’s natural response to injury or irritation, and in this case occurs following the surgical procedure.
Who can participate: You must be 18 years or older at the time of signing the informed consent, with no upper age limit. You should be scheduled for either standard phacoemulsification cataract surgery (a common type of eye surgery to remove a cloudy lens) or combined phacoemulsification cataract surgery with MIGS stent (a minimally invasive procedure to help reduce eye pressure). You need to be able to cooperate fairly well during examinations, meaning you can follow instructions and stay still during eye tests. You must also be willing to participate and capable of giving informed consent.
Who cannot participate: You cannot join if you have any other eye condition besides a cataract, if you are not within the specified age range, if you are part of a vulnerable population requiring special protection or care, or if you are unable to follow the study procedures or take the required medications.
What the trial involves: The study explores the effects of medications used to reduce inflammation after cataract surgery. Participants will use eye drops before their surgery and different eye drops after the procedure. The trial monitors inflammation levels in the eye after surgery to assess the effectiveness of the medications in improving recovery and outcomes.
Investigational drugs: The medications being studied include NEVANAC (nepafenac), a non-steroidal anti-inflammatory drug (NSAID) that helps reduce inflammation and pain, and Spersadex (dexamethasone), a corticosteroid that also helps reduce inflammation. These medications work at the molecular level by inhibiting substances in the body that cause inflammation, helping to manage the body’s response after surgery.
Study on the Effect and Safety of Phenylephrine Hydrochloride, Tropicamide, and Lidocaine Hydrochloride in Children with Cataracts Undergoing Surgery
This trial is studying the effects and safety of a medication called Mydrane in children undergoing surgery for pediatric cataract. The study aims to evaluate how well this medication works and how safe it is when used in young patients.
Who can participate: Children aged 8 weeks to 17 years old who are scheduled for surgical repair of a cataract in one or both eyes can participate. Both boys and girls are eligible for the study.
What the trial involves: During cataract surgery, children will receive an injection of Mydrane directly into the eye. This medication is a combination of three substances: phenylephrine hydrochloride, tropicamide, and lidocaine hydrochloride. These substances work together to dilate the pupil (make the opening in the center of the eye larger) and provide local anesthesia to numb the area and prevent pain during the procedure. The study will monitor how well the pupil dilates, which is important for performing the surgery without needing additional mechanical dilation. Heart rate and blood pressure will also be monitored to ensure the medication’s safety.
Investigational drug: Mydrane is a medication administered as an injection into the eye during surgery. It helps dilate the pupil, making the black part of the eye larger so the surgeon can see inside better. At the molecular level, Mydrane works by blocking certain receptors in the eye that control pupil size, allowing the pupil to remain open during the operation. It is classified as a mydriatic agent, which is specifically used to dilate the pupil for surgical procedures.
Summary
The three ongoing clinical trials for cataract represent diverse approaches to improving surgical outcomes and post-operative care. Two of the three trials are being conducted in Belgium, with one trial taking place in Norway, showing a concentration of research activity in Northern European countries.
A notable pattern across these trials is the focus on managing inflammation after surgery, with two studies specifically investigating different anti-inflammatory medications and delivery methods. The medications being tested include dexamethasone, diclofenac, and nepafenac, with one study specifically comparing preservative-free formulations to preserved versions.
Interestingly, one trial focuses exclusively on pediatric patients (children aged 8 weeks to 17 years), addressing the specific needs of younger patients undergoing cataract surgery. The other two trials target adult populations, with one specifically requiring participants to be 60 years or older.
These studies collectively aim to refine treatment protocols, reduce post-surgical complications, and improve the overall experience and outcomes for patients undergoing cataract surgery across different age groups.
