RecruitingEarly Phase 1

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%

United States20 participantsStarted 2023-09-01

Plain-language summary

This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Able to provide informed consent
✓. Undergoing cataract surgery immediately followed by pars plana vitrectomy
✓. Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters)
✓. Willing and able to comply with all study procedures
✓. Male or female, aged ≥ 18 years

Exclusion criteria

✕. Age \< 18
✕. Participating in another clinical trial
✕. Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)
✕. Previous vitrectomy
✕. Complications at the time of cataract surgery
✕. A tear in the posterior capsule

What they're measuring

Concentration of ketorolac in the vitreous humor

Timeframe: The day of surgery

Trial details

NCT IDNCT06539637

SponsorDHS Consulting

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

Contact for this trial

Eric Donnenfeld, MD

516 804 5200 ericdonnenfeld@gmail.com

View on ClinicalTrials.gov More Cataract trials