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Dropless Regimen for Cataract Surgery

Phase 4

Recruiting

Led By Sriranjani P Padmanabhan, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post operative month 1

Awards & highlights

Study Summary

This trial is testing whether a single antibiotic and steroid drop given at the time of surgery can replace the current postoperative eye drop regimen for cataract surgery patients at Zuckerberg San Francisco General Hospital.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions to the intraocular antibiotic or subconjunctival steroid such as increased eye pressure or inflammation. However, these risks are generally considered low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post operative month 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post operative month 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and post operative month 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Caregiver Satisfaction

Patient Compliance with Postoperative Regimen

Patient Satisfaction

Secondary outcome measures

Clinically Significant Cystoid Macular Edema

Endophthalmitis

Intraocular Pressure

+2 more

Trial Design

2Treatment groups

Active Control

Group I: Standard RegimenActive Control1 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 RegimenActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,485 Total Patients Enrolled

6 Trials studying Surgery

2,396 Patients Enrolled for Surgery

Sriranjani P Padmanabhan, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Dropless Regimen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05157113 — Phase 4

Surgery Research Study Groups: Standard Regimen, Dropless Regimen

Surgery Clinical Trial 2023: Dropless Regimen Highlights & Side Effects. Trial Name: NCT05157113 — Phase 4

Dropless Regimen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157113 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Standard Regimen been granted a U.S. Food and Drug Administration (FDA) stamp of approval?

"Our Power team rated Standard Regimen with a score of 3 due to its Phase 4 status, which indicates that this treatment has already been approved."

Answered by AI

What is the primary aim of this clinical experiment?

"This clinical trial will track patient behaviour over the course of Post Operative Month 1 and its primary aim is to assess patient adherence with postoperative instructions. Secondary objectives include measuring Intraocular Pressure, Snellen Visual Acuity, and Clinically Significant Cystoid Macular Edema in order to draw conclusions on efficacy."

Answered by AI

How many participants are being enrolled in this medical experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this medical trial initiated recruitment process in May of 2022 and is actively seeking participants as of November 28th that same year. 70 individuals must be recruited from one location for successful completion of the study."

Answered by AI

Is recruitment for this investigation still ongoing?

"Affirmative. The details published on clinicaltrials.gov demonstrate that this trial is actively recruiting suitable candidates, which was first posted on May 31st 2022 and has since been updated on November 28th 2022. 70 participants are required at one medical facility for enrollment in the study."

Answered by AI

Recent research and studies

Journal of Cataract and Refractive SurgeryJournal

Decreased Postoperative Endophthalmitis Rate After Institution of Intracameral Antibiotics in a Northern California Eye Department

Shorstein, Neal H., Kevin L. Winthrop, and Lisa J. Herrinton. 2013. “Decreased Postoperative Endophthalmitis Rate After Institution of Intracameral Antibiotics in a Northern California Eye Department”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jcrs.2012.07.031.

OphthalmologyJournal

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

Shorstein, Neal H., Liyan Liu, Michael D. Waxman, and Lisa J. Herrinton. 2015. “Comparative Effectiveness of Three Prophylactic Strategies to Prevent Clinical Macular Edema After Phacoemulsification Surgery”. Ophthalmology. Elsevier BV. doi:10.1016/j.ophtha.2015.08.024.

clinicaltrials.govStudy

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

2022. "Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157113.

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