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Study on Reducing Inflammation After Cataract Surgery Using Nepafenac and Dexamethasone for Patients Undergoing Surgery

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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 effects of medications used in patients undergoing surgery for cataracts, which is a condition where the lens of the eye becomes cloudy, leading to vision problems. The study will explore how different medication regimens can affect inflammation inside the eye after surgery. Inflammation is the body's response to injury or irritation, and in this case, it occurs in the eye following the surgical procedure.

The medications being studied include NEVANAC (nepafenac) and Spersadex (dexamethasone), both of which are administered as eye drops. NEVANAC is a non-steroidal anti-inflammatory drug (NSAID) that helps reduce inflammation and pain, while Spersadex is a corticosteroid that also helps in reducing inflammation. The study will compare the effects of these medications on postoperative inflammation to determine the best approach for managing inflammation after cataract surgery.

Participants in the study will receive one of the medication regimens before their cataract surgery. The study will monitor the level of inflammation in the eye after the surgery to assess the effectiveness of the medications. The goal is to find the most effective way to manage inflammation, which can help improve recovery and outcomes for patients undergoing cataract surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be 18 years or older and scheduled for cataract surgery. The ability to cooperate during examinations is required.
Step 2
Preoperative medication
Before cataract surgery, participants will use NEVANAC 3 mg/ml eye drops, suspension. This medication is applied to the eyes to help reduce inflammation. The exact dosage and frequency will be provided by the healthcare team.
Step 3
Cataract surgery
Participants undergo standard phacoemulsification cataract surgery. Some may also have a MIGS stent placed if scheduled for combined surgery.
Step 4
Postoperative medication
After surgery, participants will use Spersadex 1 mg/ml eye drops, solution. This medication is applied to the eyes to manage inflammation. The healthcare team will provide specific instructions on dosage and frequency.
Step 5
Follow-up and monitoring
Participants will attend follow-up appointments to monitor recovery and measure inflammation levels, specifically looking at laser flare as a primary endpoint.

Who can join the trial?

5 criteria

Patients must be **18 years and older** at the time of signing the informed consent. There is no upper age limit.
Scheduled for **standard phacoemulsification cataract surgery**. This is a common type of eye surgery to remove a cloudy lens, known as a cataract.
Scheduled for **combined phacoemulsification cataract surgery and MIGS stent**. MIGS stands for Minimally Invasive Glaucoma Surgery, which is a procedure to help reduce eye pressure.
Ability to **cooperate fairly well during the examinations**. This means being able to follow instructions and stay still during eye tests.
Willing to participate in the study and capable of giving **informed consent**. This means understanding the study and agreeing to follow its rules and requirements.

Who cannot join the trial?

4 criteria

Patients who have any other eye condition besides a cataract cannot participate. A cataract is when the lens of the eye becomes cloudy, affecting vision.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, meaning those who might need special protection or care, are not eligible.
Patients who are not able to follow the study procedures or take the required medications cannot participate.

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

NSAIDs are medications used to reduce inflammation and pain. In this trial, they are being studied to see how effective they are in reducing inflammation after cataract surgery. These medications are given before the surgery to see if they can help decrease the inflammation that often occurs after the procedure.

What is already known about the treatment

Ketorolac – Ketorolac is administered as an eye drop and is used to reduce inflammation and pain after cataract surgery. It is currently well-established in medical practice and literature for its effectiveness in managing postoperative eye inflammation. The main therapeutic indication for Ketorolac in this context is to minimize intraocular inflammation following cataract surgery. At the molecular level, Ketorolac works by inhibiting the cyclooxygenase (COX) enzymes, which are involved in the production of prostaglandins, substances that mediate inflammation and pain. It is classified pharmacologically as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Cataract – A cataract is a clouding of the eye's natural lens, which lies behind the iris and the pupil. It is the most common cause of vision loss in people over age 40 and is the principal cause of blindness in the world. Cataracts develop slowly and can affect one or both eyes. As the cataract progresses, it may lead to symptoms such as blurred vision, difficulty with glare, and faded colors. Over time, the clouding can become dense enough to significantly impair vision. Cataracts are typically related to aging, but can also result from trauma, radiation exposure, or certain medications.