Comparing complication rates in cataract surgery with different pre-operative treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study evaluates the complication rates in patients undergoing bilateral cataract extraction. Participants will have one eye treated with a combination of pre-operative NSAIDs, OMIDRIA, and subconjunctival triamcinolone acetonide, while the fellow eye will receive standard of care treatments. The study aims to assess the effectiveness of the new treatment regimen compared to traditional methods in reducing postoperative complications. Patients will be monitored throughout the study for adherence to treatment and outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult participants \> 18 years of age undergoing bilateral cataract surgery
* Able to provide written informed consent prior to any study related procedure
* Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
* Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months
* Participants who do not meet the exclusion criteria may be enrolled.

Exclusion Criteria:

* Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
* Glaucoma patients or known steroid responders
* Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
* Intraocular injection within 6 months
* Any prior ocular implant
* Diagnosis of retinal thickening in the study eye within 12 months of enrollment
* Inability to provide informed consent
* Participation in another clinical trial

Where it's running

• The Eye Associates - Venice
  Venice, Florida, United States Recruiting
• The Eye Centers of Racine & Kenosha
  Racine, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Paul Singh, MD — The Eye Centers of Racine & Kenosha
• Study coordinator: Paul Singh, MD
• Email: ipsingh@amazingeye.com
• Phone: 262-637-0500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.