跳至主要内容
临床试验/NCT05157113
NCT05157113招募中4 期

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

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年5月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
70
试验地点
1
主要终点
Patient Compliance with Postoperative Regimen

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Dropless Regimen

Active Comparator
  • 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.

干预措施: Dropless Regimen (Drug)

Standard Regimen

Active Comparator
  • 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.

干预措施: Standard Regimen (Drug)

结局指标

主要结局

Patient Compliance with Postoperative Regimen

时间窗: Post Operative Month 1

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."

Patient Satisfaction

时间窗: Post Operative Month 1

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.

Caregiver Satisfaction

时间窗: Post Operative Month 1

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.

次要结局

  • Snellen Visual Acuity(Post Operative Month 1)
  • Clinically Significant Cystoid Macular Edema(Post Operative Month 1)
  • Rebound Anterior Uveitis(Post Operative Month 1)
  • Intraocular Pressure(Post Operative Month 1)
  • Endophthalmitis(Post Operative Week 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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