Clinical trial NCT06539637: 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%
Official title: 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%
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cataract
Lead sponsor: DHS Consulting
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Concentration of ketorolac in the vitreous humor
timeFrame: The day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Westbury
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Eric Donnenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: