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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult participants \> 18 years of age undergoing bilateral cataract surgery - Able to provide written willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form - Participation in another clinical trial Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}

Eyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL).

DRUG

Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}

On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of surgery while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) * Any time in postoperative recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%)

Locations (2)

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