RECRUITINGPhase 4INTERVENTIONAL

Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population

Evaluating the Efficacy, Compliance, and Patient Satisfaction of a New Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population

About This Trial

The current postoperative cataract surgery eye drop regimen used at Zuckerberg San Francisco General Hospital (ZSFG) is a significant burden for its patient population, contributing to high rates of non-adherence and the development of postoperative complications. The investigators propose to replace this complex regimen with a single administration of intraocular antibiotic and subconjunctival steroid at the time of surgery. This pilot study will obtain the preliminary data required to eventually fully evaluate this innovation in postoperative care in a safety-net population with respect to postoperative outcomes, patient compliance, and patient and caregiver satisfaction.

Who May Be Eligible (Plain English)

Who May Qualify: - ZSFG patient initially seen in the eye clinic, approved by attending ophthalmologist for cataract surgery in both eyes due to visually significant cataracts, and who elects to have cataract surgery in both eyes. - Patients 18 years of age or older Who Should NOT Join This Trial: - Patients requiring bilateral simultaneous (same-day bilateral) cataract surgery - Patients with prior history of: endophthalmitis, advanced glaucoma, known history of intraocular pressure elevation due to steroids, prior intraocular surgery, cystoid macular edema/diabetic macular edema/retinal edema noted in the past 12 months prior to cataract surgery - Patients with documented penicillin or cephalosporin allergy or intolerance - Patients requiring combined same day cataract and ophthalmic subspecialty procedure (eg; combined cataract and glaucoma, retina, or cornea surgery). - Patients who are pregnant or breastfeeding Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion criteria: * ZSFG patient initially seen in the eye clinic, approved by attending ophthalmologist for cataract surgery in both eyes due to visually significant cataracts, and who elects to have cataract surgery in both eyes. * Patients 18 years of age or older Exclusion criteria: * Patients requiring bilateral simultaneous (same-day bilateral) cataract surgery * Patients with prior history of: endophthalmitis, advanced glaucoma, known history of intraocular pressure elevation due to steroids, prior intraocular surgery, cystoid macular edema/diabetic macular edema/retinal edema noted in the past 12 months prior to cataract surgery * Patients with documented penicillin or cephalosporin allergy or intolerance * Patients requiring combined same day cataract and ophthalmic subspecialty procedure (eg; combined cataract and glaucoma, retina, or cornea surgery). * Patients who are pregnant or breastfeeding

Treatments Being Tested

DRUG

Dropless Regimen

Intraoperative subconjunctival injection of triamcinolone acetonide (20mg) delivered 4-5 mm posterior to the limbus at the end of surgery. Intraoperative intracameral injection of cefuroxime delivered at the end of surgery. No postoperative drops.

DRUG

Standard Regimen

Intraoperative intracameral injection of cefuroxime delivered at the end of surgery. Neomycin/Polymyxin B ophthalmic solution: one drop to the operative eye four times daily for 1 week, then stop. Ketorolac 0.5% ophthalmic solution: one drop to the operative eye four times daily for 1 month or until the bottle runs out. Prednisolone acetate 1% ophthalmic solution: one drop to the operative eye four times daily for 1 month, then stop.

Locations (1)

Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)

San Francisco, California, United States