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%

NCT ID: NCT06539637

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-02-28

Brief 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.

Detailed 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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: COMBINATION_PRODUCT

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Interventions

OMIDRIA (*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

Intervention Type: COMBINATION_PRODUCT

Ketorolac 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DHS Consulting

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Donnenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Locations

Ophthalmic Consultants of Long Island

Westbury, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eric Donnenfeld, MD

Role: CONTACT

ericdonnenfeld@gmail.com

516 804 5200

Facility Contacts

Eric Donnenfeld, MD

Role: primary

516-804-5200

Eric Sigler, MD

Role: backup

516 804 5200

Other Identifiers

00068701

Identifier Type: -

Identifier Source: org_study_id