RecruitingEarly Phase 1NCT06539637

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%

Sponsor

DHS Consulting

Enrollment

20 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Cataract

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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

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Interventions

COMBINATION_PRODUCTOMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}

10.16 mg/mL (1% w/v) of phenylephrine {Generic Name: Biorphen} (Adrenergic Receptor Agonist) and 2.88 mg/mL (0.3% w/v) of ketorolac {Generic Name: TORADOL} (Nonsteroidal Anti-inflammatory) - via intracameral delivery

OTHERKetorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop

Topical ketorolac tromethamine {TORADOL, Nonsteroidal Anti-inflammatory} (0.5%) administered 4 times daily for the 3 days leading up to surgery. The last drop is to be given at least 2 hours prior to surgery.