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/26409728Actively Recruiting
Led by University of California, San Francisco · Updated on 2025-07-23
70
Participants Needed
1
Research Sites
N/A
Total Duration
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
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
Total: 1 location
1
Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)
San Francisco, California, United States, 94110
Actively Recruiting
S
Sriranjani Padmanabhan, MD
N
Nicole Xin, BA
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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Neal H Shorstein, Liyan Liu, Michael D Waxman...
https://pubmed.ncbi.nlm.nih.gov/26409728Neal H Shorstein, Kevin L Winthrop, Lisa J Herrinton
https://pubmed.ncbi.nlm.nih.gov/23036356