Clinical trial NCT05157113: Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Official title: Evaluating the Efficacy, Compliance, and Patient Satisfaction of a New Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Surgery
Compliance, Patient
Compliance, Medication
Satisfaction, Patient
Keywords: cataract surgery
post-operative care
vulnerable populations
compliance
patient satisfaction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed description: Frequent postoperative drop usage is a burden for vulnerable or indigent patients, who face significant barriers in maintaining standard postoperative regimens, contributing to higher rates of postoperative drop noncompliance and complications. Currently, patients undergoing cataract surgery at Zuckerberg San Francisco General Hospital, a safety-net county hospital, are started on a standard regimen of several different eye drops as part of routine postoperative recovery from cataract surgery and prophylaxis against the most troubling known postsurgical complications: endophthalmitis (devastating intraocular infection) and cystoid macular edema (CME; fluid collections in the retina causing distortion of visual acuity). On an internal review of clinic data, approximately 40% of patients undergoing cataract surgery at ZSFG are non-adherent or only partially adherent with postoperative eye drops due to a variety of causes, including difficulty instilling drops, remembering or understanding the drop regimen, and keeping physical track of multiple bottles without losing them or having them stolen. As the prevalence of comorbid ocular pathologies requiring separate chronic drop therapy (such as glaucoma) is high in this population, these difficulties are compounded with increasing numbers of eye drops and high frequency and complexity of the drop regimens. Together, these challenges have led to a frustrating rate of postoperative complications in this clinic population, particularly the rate of CME, which is approximately twice the national rate. Identifying a postoperative regimen that is feasible for surgeons, convenient for patients, and effective in preventing postoperative complications is therefore imperative particularly for this vulnerable cohort.

Recent retrospective studies suggest that single injections of cefuroxime and triamcinolone acetonide within the eye at the time of surgery is safe and noninferior to standard drop regimens in preventing postoperative complications among non-indigent patients. The investigators hypothesize that this dropless regimen would have several important benefits in this cohort of vulnerable patients: increases in patient and caregiver satisfaction, improvements in adherence with other treatment plans within the first postoperative month when not burdened with postoperative drops, and a more desirable overall cost effectiveness for all payers. The investigators further estimate that the regimen may actually be superior to the standard regimen in preventing postoperative complications in this population, given the high rate of patient non-adherence to the standard postoperative care. By employing a prospective, crossover design randomizing the eyes of patients requiring bilateral sequential cataract surgery to either the standard drop regimen or the dropless technique and following the outcomes through the first postoperative month, the investigators aim to demonstrate a significant improvement in patient and caregiver satisfaction, and adherence to all medications during the postoperative period of patients receiving the dropless regimen as compared to patients receiving the standard regimen. Additionally, in this initial small pilot, the investigators anticipate demonstrating a trend towards superiority in prevention of adverse post-surgical outcomes in the dropless cohort.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Compliance with Postoperative Regimen
timeFrame: Post Operative Week 1
measure: Patient Compliance with Postoperative Regimen
timeFrame: Post Operative Month 1
measure: Patient Satisfaction
timeFrame: Post Operative Month 1
measure: Caregiver Satisfaction
timeFrame: Post Operative Month 1
Secondary outcomes:
measure: Snellen Visual Acuity
timeFrame: Post Operative Month 1
measure: Clinically Significant Cystoid Macular Edema
timeFrame: Post Operative Month 1
measure: Rebound Anterior Uveitis
timeFrame: Post Operative Month 1
measure: Intraocular Pressure
timeFrame: Post Operative Month 1
measure: Endophthalmitis
timeFrame: Post Operative Week 1
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sriranjani P Padmanabhan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shorstein NH, Liu L, Waxman MD, Herrinton LJ. Comparative Effectiveness of Three Prophylactic Strategies to Prevent Clinical Macular Edema after Phacoemulsification Surgery. Ophthalmology. 2015 Dec;122(12):2450-6. doi: 10.1016/j.ophtha.2015.08.024. Epub 2015 Sep 26.
citation: Shorstein NH, Winthrop KL, Herrinton LJ. Decreased postoperative endophthalmitis rate after institution of intracameral antibiotics in a Northern California eye department. J Cataract Refract Surg. 2013 Jan;39(1):8-14. doi: 10.1016/j.jcrs.2012.07.031. Epub 2012 Oct 2.