Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05157113

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

Led by University of California, San Francisco · Updated on 2025-07-23

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new dropless postoperative regimen after cataract surgery in a vulnerable, county-hospital population. This study aims to address the high burden and challenges faced by patients using multiple postoperative eye drops, which contribute to non-adherence and increased rates of complications like cystoid macular edema. The investigation is a phase 4 trial conducted by the University of California, San Francisco, focusing on improving postoperative outcomes, patient compliance, and satisfaction in a safety-net hospital setting. The study compares two treatment approaches for patients undergoing bilateral sequential cataract surgery. One group receives a dropless regimen involving a single intraoperative injection of triamcinolone acetonide and cefuroxime with no postoperative eye drops. The other group follows the standard regimen, which includes intracameral cefuroxime during surgery plus multiple postoperative eye drops for several weeks. Patients are randomized to receive each regimen in one eye, allowing direct comparison within individuals. Participants will be followed through the first postoperative month, with assessments of patient and caregiver satisfaction, medication adherence, visual acuity, and the incidence of complications such as cystoid macular edema and endophthalmitis. Data collection includes evaluations at one week and one month after surgery. This pilot study aims to gather preliminary evidence on the new regimen’s safety, compliance, and satisfaction to inform future broader evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient initially seen in the eye clinic at Zuckerberg San Francisco General Hospital and approved for cataract surgery in both eyes
  • Patients 18 years of age or older
Not Eligible

You will not qualify if you...

  • Patients requiring bilateral simultaneous (same-day bilateral) cataract surgery
  • History of endophthalmitis, advanced glaucoma, steroid-related intraocular pressure elevation, prior intraocular surgery, or retinal edema within 12 months prior to surgery
  • Documented allergy or intolerance to penicillin or cephalosporin antibiotics
  • Patients requiring combined cataract and other ophthalmic subspecialty surgery on the same day
  • Pregnant or breastfeeding patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo cataract surgery during which they receive either the dropless regimen or the standard postoperative eye drop regimen.

1 visit (in-person)

Postoperative Treatment

Duration - Up to 1 month

Participants receive either intraoperative injections without postoperative drops or standard postoperative eye drops according to the assigned regimen.

Weekly visits for up to 4 weeks

Follow-up Assessment

Duration - 1 month post surgery

Participants are monitored for patient and caregiver satisfaction, adherence to treatment, and postoperative complications during the first postoperative month.

1 follow-up visit at 1 month post surgery

Trial Site Locations

Total: 1 location

1

Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)

San Francisco, California, United States, 94110

Actively Recruiting

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Research Team

S

Sriranjani Padmanabhan, MD

N

Nicole Xin, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Comparative Effectiveness of Three Prophylactic Strategies to Prevent Clinical Macular Edema after Phacoemulsification Surgery.

Neal H Shorstein, Liyan Liu, Michael D Waxman...

https://pubmed.ncbi.nlm.nih.gov/26409728

Decreased postoperative endophthalmitis rate after institution of intracameral antibiotics in a Northern California eye department.

Neal H Shorstein, Kevin L Winthrop, Lisa J Herrinton

https://pubmed.ncbi.nlm.nih.gov/23036356