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%

DHS Consulting

Status and phase: Enrolling; Early Phase 1

Conditions: Cataract

Treatments: Combination Product: OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}; Other: Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop

Study type: Interventional

Funder types: Other

Identifiers

NCT06539637

00068701

Details and patient eligibility

About

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.

Full description

Cataract surgery can result in intra- and postoperative inflammation. Various strategies are employed to prevent and combat this inflammatory reaction, including preoperative topical NSAIDs, intraoperative NSAIDs or steroids, and postoperative topical NSAIDs and/or steroids. The only FDA-approved NSAID for intraoperative use is the ketorolac component of OMIDRIA® (Rayner Surgical, Bellevue, WA, USA).

Animal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively. There is no human data for ketorolac levels in the vitreous following intracameral administration of OMIDRIA at the time of cataract surgery.

This study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy. Aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

OMIDRIA

Active Comparator group

Description:

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.

Treatment:

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

Topical Ketorolac

Active Comparator group

Description:

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.

Treatment:

Other: Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop