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%

Last updated: August 1, 2024
Sponsor: DHS Consulting
Overall Status: Active - Recruiting

Phase

1

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

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

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

Clinical Study ID

NCT06539637
00068701
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Age < 18

  2. Participating in another clinical trial

  3. Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combinedprocedure)

  4. Previous vitrectomy

  5. Complications at the time of cataract surgery

  6. A tear in the posterior capsule

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}
Phase: 1
Study Start date:
September 01, 2023
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Ophthalmic Consultants of Long Island

    Westbury, New York 11590
    United States

    Active - Recruiting

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