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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05157113
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cataract
  • Compliance, Medication
  • Compliance, Patient
  • Satisfaction, Patient
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dropless Regimen — DRUG
    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.
  • Standard Regimen — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 31, 2022
Status verified
Jul 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Patient Compliance with Postoperative Regimen [ Time Frame: Post Operative Week 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)San FranciscoCalifornia94110-

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Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)· San Francisco, CA

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