Cataract
Conditions
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.
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.
Sponsors
DHS Consulting
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of ketorolac in the vitreous humor | The day of surgery | Vitreous samples taken from vitrectomy at the beginning of the procedure for all patients. |
Countries
United States
Contacts
Primary ContactEric Donnenfeld, MD
Outcome results
None listed