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

Primary Purpose

Cataract, Surgery, Compliance, Patient

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dropless Regimen
Standard Regimen
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cataract focused on measuring cataract surgery, post-operative care, vulnerable populations, compliance, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dropless Regimen

Standard Regimen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."
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."
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.
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.

Secondary Outcome Measures

Snellen Visual Acuity
Uncorrected and Best Corrected Snellen Visual Acuity Values
Clinically Significant Cystoid Macular Edema
Presence or absence of Clinically Significant Cystoid Macular Edema; assessed by clinical examination
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
Intraocular Pressure
Intraocular Pressure in mmHg; assessed by standard tonography in clinical examination
Endophthalmitis
Presence or absence of endophthalmitis; assessed by clinical examination

Full Information

First Posted
November 30, 2021
Last Updated
June 27, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05157113
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Surgery, Compliance, Patient, Compliance, Medication, Satisfaction, Patient
Keywords
cataract surgery, post-operative care, vulnerable populations, compliance, patient satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dropless Regimen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Regimen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dropless Regimen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard Regimen
Intervention Description
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 Information:
Title
Patient Compliance with Postoperative Regimen
Description
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 1
Title
Patient Compliance with Postoperative Regimen
Description
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 1
Title
Patient Satisfaction
Description
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 1
Title
Caregiver Satisfaction
Description
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 1
Secondary Outcome Measure Information:
Title
Snellen Visual Acuity
Description
Uncorrected and Best Corrected Snellen Visual Acuity Values
Time Frame
Post Operative Month 1
Title
Clinically Significant Cystoid Macular Edema
Description
Presence or absence of Clinically Significant Cystoid Macular Edema; assessed by clinical examination
Time Frame
Post Operative Month 1
Title
Rebound Anterior Uveitis
Description
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 1
Title
Intraocular Pressure
Description
Intraocular Pressure in mmHg; assessed by standard tonography in clinical examination
Time Frame
Post Operative Month 1
Title
Endophthalmitis
Description
Presence or absence of endophthalmitis; assessed by clinical examination
Time Frame
Post Operative Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sriranjani Padmanabhan, MD
Phone
415-514-0241
Email
sriranjani.padmanabhan@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Wu, BS
Phone
4158157902
Email
joshua.wu@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriranjani P Padmanabhan, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26409728
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.
Results Reference
background
PubMed Identifier
23036356
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.
Results Reference
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Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population

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