Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
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

Led by Inder Paul Singh, M.D. · Updated on 2024-11-29

94

Participants Needed

2

Research Sites

55 weeks

Total Duration

On this page

Sponsors

I

Inder Paul Singh, M.D.

Lead Sponsor

T

The Eye Associates

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old undergoing bilateral cataract surgery
  • Able to provide written informed consent before any study procedures
  • Able and willing to follow study instructions, complete assessments, and attend visits
  • Patients considered higher risk for postoperative complications may join if no active disease or treatment in past 12 months
  • Participants must not meet exclusion criteria
Not Eligible

You will not qualify if you...

  • Cataract surgery combined with other procedures (e.g., glaucoma, retina)
  • Glaucoma patients or known steroid responders
  • Use of oral anti-inflammatory medications for systemic disease (exceptions: low-dose aspirin, ibuprofen for headache)
  • Intraocular injection within last 6 months
  • Any prior ocular implant
  • Retinal thickening diagnosis in study eye within past 12 months
  • Unable to provide informed consent
  • Participation in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The Eye Associates - Venice

Venice, Florida, United States, 34292

Actively Recruiting

2

The Eye Centers of Racine & Kenosha

Racine, Wisconsin, United States, 53405

Actively Recruiting

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Research Team

P

Paul Singh, MD

CONTACT

C

Cathleen McCabe, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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