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
- Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} (drug)
- Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte} (drug)
Sponsor: Inder Paul Singh, M.D. · Participants: 94 · Started: Jul 10, 2024
Contact the study team
- Paul Singh, MD · Phone: 262-637-0500
- Cathleen McCabe, MD · Phone: 941-493-3763
Official record on ClinicalTrials.gov — NCT06681688
Locations in the U.S.
| Florida | The Eye Associates - Venice, Venice |
| Wisconsin | The 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.