Dropless Regimen for Cataract Surgery

Overseen By Nicole Xin, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Advanced glaucoma, Retinal edema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to simplify recovery after cataract surgery. Instead of multiple eye drops post-surgery, the trial examines whether a single dose of antibiotic and steroid administered during surgery (known as the Dropless Regimen) can be equally effective. The aim is to determine if this approach enhances patient compliance and satisfaction while reducing complications. The trial seeks participants approved for cataract surgery in both eyes at Zuckerberg San Francisco General Hospital. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiming to understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Dropless Regimen and Standard Regimen treatments?

Research has shown that the dropless method for cataract surgery, which involves administering antibiotics and steroids once during the operation, is generally well-tolerated. One study found that injecting a steroid called triamcinolone acetonide under the eye's outer layer resulted in over 90% of patients experiencing no significant inflammation by Day 60. This suggests the treatment effectively reduces inflammation.

However, caution is advised. Dropless cataract surgery can increase the risk of a prolonged steroid reaction, particularly in individuals with glaucoma, necessitating extra monitoring for some patients.

Overall, despite some risks, the dropless method appears safe for most patients. Consulting a doctor is crucial to determine its suitability, especially for those with existing eye conditions like glaucoma. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the dropless regimen for cataract surgery because it simplifies post-surgery care by eliminating the need for patients to use eye drops. Unlike the standard regimen, which requires multiple daily drops of antibiotics and anti-inflammatory medications for weeks after surgery, the dropless approach uses a single, intraoperative injection of triamcinolone acetonide and cefuroxime. This innovative delivery method can improve patient convenience and compliance, reducing the risk of infection or inflammation by ensuring consistent medication delivery without relying on patient adherence.

What evidence suggests that this trial's treatments could be effective for cataract surgery?

This trial will compare a dropless approach with a standard regimen for cataract surgery. Research has shown that the dropless approach, using a single injection of triamcinolone acetonide and cefuroxime during surgery, can be effective. Studies have found that increasing the amount of triamcinolone acetonide can reduce the risk of macular edema, which is swelling in the eye after surgery. Early findings suggest that a 10 mg dose of triamcinolone is a promising option for dropless cataract surgery. This method may not only work well but also eliminate the need for multiple eye drops after surgery, reducing both hassle and cost. Triamcinolone has been compared to traditional eye drop treatments and has shown similar effectiveness in preventing complications after surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Sriranjani P Padmanabhan, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery with either a standard drop regimen or a dropless regimen

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative outcomes, including patient satisfaction, compliance, and adverse events

1 month

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Dropless Regimen
• Standard Regimen

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11416342/

Triamcinolone Acetonide Subconjunctival Injection as Stand ... To compare the effectiveness and safety of a single injection of subconjunctival triamcinolone acetonide (TA) to postoperative topical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556800/

Cost analysis of dropless cataract surgery prophylaxis with ... Using an injection-based prophylaxis regimen in cataract surgery can reduce health system costs by $87.99 (84.7%) and out-of-pocket patient ...

3. aaojournal.org aaojournal.org/article/S0161-6420(24)00206-9/fulltext

Triamcinolone Acetonide Subconjunctival Injection as ... Doubling the dose of the lower-strength medication (4 mg of TA 10 mg/ml) seems to increase effectiveness, with lower odds of a postoperative ME ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642024002069

Triamcinolone Acetonide Subconjunctival Injection as ... Purpose. To compare the effectiveness and safety of a single injection of subconjunctival triamcinolone acetonide (TA) with that of postoperative topical ...

5. escrs.org escrs.org/channels/eurotimes-articles/escrs-epicat-study-updates

ESCRS EPICAT Study Updates Early results suggest subconjunctival 10 mg triamcinolone an effective strategy for dropless cataract surgery. ESCRS EPICAT Study Updates ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522460/

Steroid Response Following Dropless Cataract Surgery Using ... Dropless cataract surgery increases the risk of prolonged steroid response postoperatively. Patients with glaucoma have an increased risk of steroid response.

7. journals.lww.com journals.lww.com/tnoa/fulltext/2025/07000/safety_and_functional_outcome_of_dropless_surgery.13.aspx

Safety and Functional Outcome of Dropless Surgery Versus... Anterior chamber inflammation resolved progressively, with over 90% of patients achieving grade 0 inflammation by Day 60 in the dropless group. This parallels ...