RECRUITINGEarly Phase 1INTERVENTIONAL

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%

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to provide willing to sign a consent form 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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}

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

OTHER

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.

Locations (1)

Ophthalmic Consultants of Long Island

Westbury, New York, United States