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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 study about?

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.

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.

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.

3 cataract surgery

Participants undergo standard phacoemulsification cataract surgery. Some may also have a MIGS stent placed if scheduled for combined surgery.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
01.05.2022

Trial locations

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.

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.

Trial ID:
2024-512268-77-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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