What is the mechanism of action of this treatment?

Common treatments for cataracts, such as the intraocular antibiotic and subconjunctival steroid regimen, work by preventing infection and reducing inflammation. Antibiotics eliminate or inhibit bacterial growth, preventing postoperative infections. Steroids suppress the immune response, reducing inflammation, pain, and swelling, and minimizing complications like macular edema. These mechanisms are vital for cataract patients as they promote faster recovery, lower the risk of complications, and improve surgical outcomes.

What side effects are associated with this type of intervention?

Common treatments for cataract, such as intraocular antibiotics and subconjunctival steroids, have specific side effects. Intraocular antibiotics can cause allergic reactions, ocular tissue toxicity, and antibiotic resistance. Subconjunctival steroids, used to reduce inflammation, may lead to increased intraocular pressure, delayed wound healing, and a higher risk of infection. Monitoring for these side effects is essential to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved various treatments for cataract surgery, including the use of intraocular antibiotics and steroids to prevent infection and reduce inflammation. Commonly used antibiotics include moxifloxacin and cefuroxime, which are administered intraocularly to prevent postoperative infections. Steroids such as dexamethasone and prednisolone are often used to manage inflammation following surgery. These treatments aim to enhance recovery and minimize complications, aligning with the regimen being studied in the trial involving intraocular antibiotic and subconjunctival steroid administration.

What other types of research exist?

Promising novel alternatives for cataract patients in 2024 include the use of dropless postoperative regimens, which involve a single administration of intraocular antibiotic and subconjunctival steroid at the time of surgery. This approach aims to simplify postoperative care, improve patient compliance, and reduce the risk of postoperative complications. Additionally, advancements in sustained-release drug delivery systems and minimally invasive surgical techniques may offer further improvements in managing postoperative inflammation and infection.

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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

Must not have

Patients with prior intraocular surgery

Patients requiring bilateral simultaneous (same-day bilateral) cataract surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post operative month 1

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had eye surgery before.

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

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I have a history of advanced glaucoma.

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I have had an eye infection called endophthalmitis before.

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I have had eye pressure increases from steroids.

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I need both cataract and another eye surgery on the same day.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver Satisfaction

Patient Compliance with Postoperative Regimen

Patient Satisfaction

Secondary study objectives

Clinically Significant Cystoid Macular Edema

Endophthalmitis

Intraocular Pressure

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cataracts, such as the intraocular antibiotic and subconjunctival steroid regimen, work by preventing infection and reducing inflammation. Antibiotics eliminate or inhibit bacterial growth, preventing postoperative infections. Steroids suppress the immune response, reducing inflammation, pain, and swelling, and minimizing complications like macular edema. These mechanisms are vital for cataract patients as they promote faster recovery, lower the risk of complications, and improve surgical outcomes.

The corticosteroids effect on corneal endothelial cell in pulse therapy, specific to the cataract surgery.