Recruiting

Dropless Regimen

Sponsor:

UCLA

Code:

NCT05157113

Conditions

Cataract

Surgery

Compliance, Patient

Compliance, Medication

Satisfaction, Patient

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dropless Regimen

Standard Regimen

Study Details

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

Study ID

NCT05157113

Start date

May 31, 2022

Status verified date

Jul, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Dropless Regimen

  • 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.

active comparator: Standard Regimen

  • 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.

Interventions

Dropless Regimen

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.

Standard Regimen

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

  • Patient Compliance with Postoperative Regimen [ Time Frame: Post Operative Week 1 ]
  • Patient Compliance with Postoperative Regimen [ Time Frame: Post Operative Month 1 ]
  • Patient Satisfaction [ Time Frame: Post Operative Month 1 ]
  • Caregiver Satisfaction [ Time Frame: Post Operative Month 1 ]

Central Contacts and Locations

Central contacts

Sriranjani Padmanabhan, MD

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

Nicole Xin, BA

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

Locations

Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)

Recruiting

San Francisco, California, United States, 94110

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 23, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-07-23.