Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
Dropless Regimen
DrugIntraoperative 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
DrugIntraoperative 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Dropless RegimenActive comparator 1 intervention
Group B: Standard RegimenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Compliance with Postoperative Regimen
Compliance will be reported via a language-specific VOILS DOSE Nonadherence Survey and an in-person verbal/visual adherence check with staff. The survey is separated into two parts: Extent of Nonadherence and Reasons for Nonadherence. Extent of Nonadherence will evaluate whether medicine dosages have been skipped or missed, with a variety of options ranging from "none of the time" to "every time." Reasons for Nonadherence will present possible causes of missed/skipped dosage, with a variety of options ranging from "not at all" to "very much."
Time frame
Post Operative Week 12
Patient Compliance with Postoperative Regimen
Compliance will be reported via a language-specific VOILS DOSE Nonadherence Survey and an in-person verbal/visual adherence check with staff. The survey is separated into two parts: Extent of Nonadherence and Reasons for Nonadherence. Extent of Nonadherence will evaluate whether medicine dosages have been skipped or missed, with a variety of options ranging from "none of the time" to "every time." Reasons for Nonadherence will present possible causes of missed/skipped dosage, with a variety of options ranging from "not at all" to "very much."
Time frame
Post Operative Month 13
Patient Satisfaction
Patients will rate their post-operative recovery on a Likert Scale of 1-5, with 1 being "very unsatisfied" and 5 being "very satisfied." Supplemental questions are included to obtain the patients' opinions on their eyesight, pain, and personal experience with the post-operative routine. After undergoing a second eye surgery and post-operative treatment, the survey will be given again with an additional question asking patients to indicate their preference between the two post-operative regimens as a binary choice.
Time frame
Post Operative Month 14
Caregiver Satisfaction
Caregivers will also rate their satisfaction with the patients' post-operative recovery on a Likert Scale of 1-5, with 1 being "very unsatisfied" and 5 being "very satisfied." Supplemental questions are included to obtain the caregivers' personal experience with the post-operative routine. After the patient's second eye surgery and post-operative treatment, the survey will be given again with an additional question asking caregivers to choose between the two post-operative regimens as a binary choice.
Time frame
Post Operative Month 1Secondary outcomes
1
Snellen Visual Acuity
Uncorrected and Best Corrected Snellen Visual Acuity Values
Time frame
Post Operative Month 12
Clinically Significant Cystoid Macular Edema
Presence or absence of Clinically Significant Cystoid Macular Edema; assessed by clinical examination
Time frame
Post Operative Month 13
Rebound Anterior Uveitis
Presence or absence of Rebound Anterior Uveitis; assessed by clinical Presence or absence of Clinically Significant Cystoid Macular Edema; assessed by clinical examination
Time frame
Post Operative Month 14
Intraocular Pressure
Intraocular Pressure in mmHg; assessed by standard tonography in clinical examination
Time frame
Post Operative Month 1Sponsors and contacts
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Source ClinicalTrials.gov