Evaluating Ketorolac Levels in Eye Surgery Patients
Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3%
This study is testing how much ketorolac gets into the eye during surgery for cataracts and other eye issues to see how it helps with inflammation.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | DHS Consulting Academic / other |
| Locations | 1 site (Westbury, New York) |
| Trial ID | NCT06539637 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the levels of ketorolac in the vitreous and aqueous humor of patients undergoing combined cataract and pars plana vitrectomy surgeries. Participants will receive either intracameral OMIDRIA, which contains ketorolac, or topical ketorolac prior to surgery. The study aims to analyze the concentration of ketorolac in eye samples taken during the procedure to better understand its effects on inflammation. Approximately 10-20 patients will be enrolled, and samples will be sent to an independent lab for analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing combined cataract surgery and pars plana vitrectomy with a diagnosed structural pathology.
Not a fit: Patients undergoing cataract surgery or vitrectomy alone, or those with complications during surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative care by providing insights into effective inflammation management during eye surgeries.
How similar studies have performed: While there is animal data on ketorolac levels, this study represents a novel approach as there is no prior human data on its levels following intracameral administration during cataract surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to provide informed consent 2. Undergoing cataract surgery immediately followed by pars plana vitrectomy 3. Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters) 4. Willing and able to comply with all study procedures 5. Male or female, aged ≥ 18 years Exclusion Criteria: 1. Age \< 18 2. Participating in another clinical trial 3. Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure) 4. Previous vitrectomy 5. Complications at the time of cataract surgery 6. A tear in the posterior capsule
Where this trial is running
Westbury, New York
- Ophthalmic Consultants of Long Island — Westbury, New York, United States (Recruiting)
Study contacts
- Principal investigator: Eric Donnenfeld, MD — Ophthalmic Consultants of Long Island
- Study coordinator: Eric Donnenfeld, MD
- Email: ericdonnenfeld@gmail.com
- Phone: 516 804 5200
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.