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%
Status: Recruiting
Location: See location...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
Ophthalmic Consultants of Long Island
RECRUITING
Westbury
Contact Information
Primary
Eric Donnenfeld, MD
ericdonnenfeld@gmail.com
516 804 5200
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 20
Treatments
Active_comparator: OMIDRIA
OMIDRIA is a combination product containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial. Once the 4mL of OMIDRIA is diluted in 500 mL of ophthalmic irrigation solution, the resulting solution is intended to be used as needed during cataract surgery or intraocular lens replacement.
Active_comparator: Topical Ketorolac
Topical ketorolac tromethamine 0.5% is a nonsteroidal anti-inflammatory drug. It is FDA-approved for the treatment of inflammation following cataract surgery and relief of ocular itching due to seasonal allergic conjunctivitis.
Related Therapeutic Areas
Sponsors
Leads: DHS Consulting