Dropless Regimen for Cataract Surgery

Overseen by Sriranjani P Padmanabhan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of California, San Francisco

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial aims to replace the complex eye drop regimen after cataract surgery with a single injection during surgery. It targets vulnerable patients who struggle with multiple eye drops. The injection helps prevent infections and swelling, making post-surgery care easier and more effective.

Research Team

Sriranjani P Padmanabhan, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for patients at Zuckerberg San Francisco General Hospital who need cataract surgery in both eyes, are over 18 years old, and have been approved by an ophthalmologist. It's not for those with prior eye surgeries, certain retinal conditions within the last year, simultaneous bilateral cataract surgery needs, combined other eye procedures on the same day, or allergies to specific antibiotics.

Inclusion Criteria

I am approved for cataract surgery in both eyes due to significant vision loss.

I am 18 years old or older.

Exclusion Criteria

I have had eye surgery before.

I need cataract surgery on both eyes at the same time.

I have a history of advanced glaucoma.

Treatment Details

Interventions

• Dropless Regimen (Other)
• Standard Regimen (Other)

Trial Overview The study tests a 'dropless' postoperative care approach against the standard multiple-eye-drops regimen after cataract surgery. Patients will receive a one-time intraocular antibiotic and subconjunctival steroid during surgery instead of several post-surgery eye drops.

Participant Groups

Group I: Standard Regimen Active Control 1 Intervention

* 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.

Group II: Dropless Regimen Active Control 1 Intervention

* 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine