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

NCT05157113 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-33492
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Surgery; Compliance, Patient; Compliance, Medication; Satisfaction, Patient

Keywords

cataract surgery; post-operative care; vulnerable populations; compliance; patient satisfaction

Outcome Measures

Primary Outcomes (4)

• 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."

  Post Operative Week 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."

  Post Operative Month 1

• 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.

  Post Operative Month 1

• 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.

  Post Operative Month 1

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

Drug: Dropless Regimen

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.

Drug: Standard Regimen

Interventions

Dropless Regimen DRUG

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.

Dropless Regimen

Standard Regimen DRUG

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.

Standard Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)

San Francisco, California, 94110, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 26409728 BACKGROUND

• 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.

  PMID: 23036356 BACKGROUND

MeSH Terms

Conditions

Cataract; Patient Compliance; Medication Adherence; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sriranjani P Padmanabhan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sriranjani Padmanabhan, MD

CONTACT

415-514-0241; sriranjani.padmanabhan@ucsf.edu

Nicole Xin, BA

CONTACT

628-206-3123; nicole.xin@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: May 31, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)