Evaluating a new dropless approach for postoperative care after cataract surgery
Evaluating the Efficacy, Compliance, and Patient Satisfaction of a New Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
This study is testing a new way to care for patients after cataract surgery by using just one injection instead of multiple eye drops to see if it helps them recover better and stick to their treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05157113 on ClinicalTrials.gov |
What this trial studies
This study aims to simplify postoperative care for cataract surgery patients at Zuckerberg San Francisco General Hospital by replacing the traditional regimen of multiple eye drops with a single administration of an intraocular antibiotic and a subconjunctival steroid at the time of surgery. The focus is on a vulnerable population that often struggles with adherence to complex medication regimens, leading to higher rates of complications. By collecting preliminary data on postoperative outcomes, patient compliance, and satisfaction, the study seeks to assess the feasibility and effectiveness of this innovative approach in improving patient care. The study is interventional and is classified as Phase 4.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older who are undergoing cataract surgery in both eyes and have been approved by an ophthalmologist.
Not a fit: Patients who require same-day bilateral cataract surgery or have a history of certain ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient adherence to postoperative care and reduce complications after cataract surgery.
How similar studies have performed: While this approach is innovative for this specific population, similar studies have shown that simplifying postoperative regimens can lead to improved compliance and outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Sriranjani P Padmanabhan, MD — University of California, San Francisco
- Study coordinator: Sriranjani Padmanabhan, MD
- Email: sriranjani.padmanabhan@ucsf.edu
- Phone: 415-514-0241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.