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Study of Cataract Surgery Complication Rates

This study is looking at ways to reduce problems after cataract surgery. It compares two different approaches to medication. One approach uses a combination of medications given during surgery: Omidria (phenylephrine/ketorolac), VIGAMOX (moxifloxacin), and Kenalog (triamcinolone acetonide). The other approach uses a standard set of eye drops given before, during, and after surgery: Toradol (ketorolac), VIGAMOX (moxifloxacin), and Pred Forte (prednisolone acetate). You could join if you are an adult (over 18) having cataract surgery in both eyes. The main goal is to see how much inflammation (swelling) there is 8 days after surgery. The study is currently recruiting participants.

Study design
This is a randomized study involving 94 participants. For each participant, one eye will receive the study medication combination, and the other eye will receive standard care.
What's involved
You would need to follow study instructions, complete assessments, and attend study visits for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
Inflammation will be measured 8 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06681688

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
PHASE1Ages 18+InterventionalTreatment
Inder Paul Singh, M.D.
~94 participants
Updated 2024-11-29 on ClinicalTrials.gov
What's tested:Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
inflammation
Measured over 8 days

Conditions

Cataract

Explore related trials

Cataract

Where it's being run

2 sites across 2 states
Florida1
Wisconsin1

Study leadership

  • Paul Singh, MD · PRINCIPAL_INVESTIGATOR · The Eye Centers of Racine & Kenosha

Who to contact

Paul Singh, MD
[email protected]
262-637-0500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • inflammation8 days

    The proportion of participants with inflammation on Day 8. (Participants will be considered to have no inflammation (Grade 0) if they have ≤ 2 anterior chamber cells and are asymptomatic.) {Anterior Inflammation Scale, 0-4 with 4 being the worst or most severe score}