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

Description

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.

Conditions

Cataract

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cataract
Intervention / Treatment

-

Contacts and Locations

Venice

The Eye Associates - Venice, Venice, Florida, United States, 34292

Racine

The Eye Centers of Racine & Kenosha, Racine, Wisconsin, United States, 53405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inder Paul Singh, M.D.,

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

Study Record Dates

2025-08