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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Inder Paul Singh, M.D. · Participants: 94 · Started: Jul 10, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06681688

Locations in the U.S.

FloridaThe Eye Associates - Venice, Venice
WisconsinThe Eye Centers of Racine & Kenosha, Racine

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.