Comparing complication rates in cataract surgery with different pre-operative treatments
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
This study tests if a new combination of eye treatments before cataract surgery can lower the risk of complications compared to standard care.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Eye Centers of Racine and Kenosha Academic / other |
| Locations | 2 sites (Venice, Florida and 1 other locations) |
| Trial ID | NCT06681688 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized study evaluates the complication rates in patients undergoing bilateral cataract extraction. Participants will have one eye treated with a combination of pre-operative NSAIDs, OMIDRIA, and subconjunctival triamcinolone acetonide, while the fellow eye will receive standard of care treatments. The study aims to assess the effectiveness of the new treatment regimen compared to traditional methods in reducing postoperative complications. Patients will be monitored throughout the study for adherence to treatment and outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing bilateral cataract surgery and are at higher risk for postoperative complications.
Not a fit: Patients undergoing cataract surgery combined with other procedures or those with glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced complication rates for cataract surgery patients.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Venice, Florida and 1 other locations
- The Eye Associates - Venice — Venice, Florida, United States (Recruiting)
- The Eye Centers of Racine & Kenosha — Racine, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Paul Singh, MD — The Eye Centers of Racine & Kenosha
- Study coordinator: Paul Singh, MD
- Email: ipsingh@amazingeye.com
- Phone: 262-637-0500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.