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

Who is this study for? Patients undergoing cataract surgery in both eyes due to visually significant cataracts
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)
RECRUITING
San Francisco
Contact Information
Primary
Sriranjani Padmanabhan, MD
sriranjani.padmanabhan@ucsf.edu
415-514-0241
Backup
Nicole Xin, BA
nicole.xin@ucsf.edu
628-206-3123
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 70
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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