Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC

Recruiting now · Phase 1/Phase 2

Conditions studied: Cataract

In brief

This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.

Key facts

Study ID

NCT06681688

Run by

Inder Paul Singh, M.D.

People needed

94

Starts

2024-07-10

Expected to finish

2025-08-01

Last updated by the study team

2024-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• The Eye Associates - Venice — Venice, Florida, United States (enrolling)
• The Eye Centers of Racine & Kenosha — Racine, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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