Triamcinolone + Clobetasol for Cataract Surgery

(TRIBECA Trial)

Overseen By John Hovanesian, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Research Insight LLC

Must not be taking: Steroids, NSAIDs

Disqualifiers: Glaucoma, Diabetes, Retinal changes, 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: 4

Duration: 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to manage pain and inflammation after cataract surgery. It compares the effects of delivering triamcinolone (a steroid) and clobetasol (a topical medication) with existing treatments such as prednisolone and antibiotic eye drops. The goal is to determine which method is safer, more effective, and more acceptable to patients. This trial may suit individuals planning cataract surgery in both eyes, who do not have other eye issues like inflammation or past trauma. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people who need medications that might affect vision, eye inflammation, or pain. It's best to discuss your specific medications with the trial team.

What is the safety track record for these treatments?

Research has shown that triamcinolone, the drug tested in this trial, has been studied for safety in other contexts. One study found that using triamcinolone during cataract surgery did not significantly increase eye pressure over time, suggesting it is generally well-tolerated. However, some patients experienced more cataracts after using triamcinolone, which is important to consider regarding its overall safety.

For clobetasol, clear safety information is not available from the sources provided here. However, as this is a Phase 4 trial, the treatment has already been approved for use in other conditions, usually indicating a known safety profile.

Participants should consider these findings when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Triamcinolone and Clobetasol for cataract surgery because it introduces a new approach by using a combination of steroids not commonly paired in current treatments. While standard care typically involves topical antibiotics and anti-inflammatory drugs like Moxifloxacin and Ketorolac, this trial explores the potential benefits of intraocular steroid delivery with Triamcinolone. This method aims to reduce inflammation more effectively and with longer-lasting results, potentially minimizing the need for frequent topical applications. Additionally, the use of Clobetasol provides a potent anti-inflammatory effect that might enhance healing and improve patient outcomes after surgery.

What evidence suggests that this trial's treatments could be effective for controlling postoperative pain and inflammation in cataract surgery?

Research has shown that triamcinolone, an injection given during cataract surgery, works as well as steroid pills for managing swelling. This treatment has successfully reduced complications during cataract surgery, particularly in children. In this trial, participants in the experimental group will receive triamcinolone. One study found that a single injection of triamcinolone is as effective and safe as steroid eye drops after surgery. These findings suggest that triamcinolone can effectively control swelling and pain following cataract surgery. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

The TRIBECA Study is for individuals undergoing sequential bilateral cataract surgery. Participants must be suitable for the procedure and willing to follow postoperative medication instructions. Specific eligibility criteria are not provided, but typically participants should not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

Subject with normal OCT of the macula in both eyes

Subject has the potential for a post-operative Snellen BCDVA of 20/30 or better in both eyes

I understand the study and agree to participate.

Exclusion Criteria

Subject with a known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) or to any component of the test article

Subject with amblyopia or strabismus

Subject with an inability to achieve keratometric stability for contact lens wearers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a subconjunctival injection of triamcinolone or topical clobetasol, along with nepafenac and moxifloxacin, or a conventional regimen of prednisolone, ketorolac, and moxifloxacin

14 days

1 visit (in-person) at 1 day, 1 week, and 1 month postoperatively

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of ocular pain and inflammation

1 month

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone

Trial Overview

This study tests if subconjunctival triamcinolone (Triesence) after surgery, or topical clobetasol (Byqlovi) twice daily for two weeks, combined with standard medications, is as effective as traditional postoperative eye drops in controlling pain and inflammation after cataract surgery.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Triesence or Byqlovi Arm with nepafenac

Group II: Control Group Active Control 1 Intervention

Topical Moxifloxacin, Ketorolac, Prednisolone Acetate

Who Is Running the Clinical Trial?

Research Insight LLC

Lead Sponsor

Trials

13

Recruited

900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07276802

The TRIBECA Study (TRIessence/Byqlovi for Easier ...

The purpose of this study is to evaluate the safety, effectiveness and patient acceptance of two post cataract surgery drug treatment regimens ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11627093/

Long-term outcomes of intraoperative triamcinolone injection ...

Subsequently, in a randomized controlled trial, we found that intracameral triamcinolone injection was as effective as oral steroids in modulating ocular ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2950253524000935

Clinical outcomes of triamcinolone acetonide in pediatric ...

Intracameral injection of TA was superior to surgery without TA in reducing VAO and posterior synechiae in pediatric cataract surgery with IOL implantation.

4.

e-century.us

e-century.us/files/ijcem/12/6/ijcem0078805.pdf

Review Article The influence of triamcinolone acetonide on ...

The intracameral injection of triamcinolone acetonide shows safe and positive results in the pediatric population during cataract surgery, with ...

5.

aaojournal.org

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

Triamcinolone Acetonide Subconjunctival Injection as ...

To compare the effectiveness and safety of a single injection of subconjunctival triamcinolone acetonide (TA) with that of postoperative topical prednisolone ...

6.

jamanetwork.com

jamanetwork.com/journals/jamaophthalmology/fullarticle/416158

Safety of an Intravitreal Injection of Triamcinolone

There was significant progression of cataract in the triamcinolone-treatedeyes. By the 24-month visit, 8 (24.2%) of 33 triamcinolone-treated eyes ...

7.

escrs.org

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

ESCRS EPICAT Study Updates

The preliminary results of the ESCRS EPICAT study showed that triamcinolone 10 mg is an effective dropless strategy for the prevention of CME or ...