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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Final enrollment: 51 participants (planned 70)
    • Primary completion date changed from estimate of Jun 1, 2026 to Apr 2, 2025
    • Eligibility criteria expanded, about 7 words
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Notable Primary and study completion dates: Jun 1, 2024 to Jun 1, 2026v8
  3. Notable Primary and study completion dates: Mar 1, 2023 to Jun 1, 2024v7
  4. Minor Re-verified, no change to tracked fieldsv6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
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  1. Notable Start date: Apr 11, 2022 to May 31, 2022v4
  2. Notable Start date: Mar 1, 2022 to Apr 11, 2022v3
  3. Minor Secondary endpoints: details revised at 2 of 5 entriesv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05157113
Lead Sponsor University of California, San Francisco
Conditions
(from sponsor)
Cataract, Surgery, Compliance, Patient, Compliance, Medication, Satisfaction, Patient
Related terms Cataract, Medication Adherence, Patient Compliance, Patient Satisfaction
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov