Combined Pre-operative Treatment for Cataracts

Recruiting at 1 trial location

Overseen By Cathleen McCabe, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Inder Paul Singh, M.D.

Must not be taking: Oral anti-inflammatories

Disqualifiers: Glaucoma, Steroid responders, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for individuals undergoing cataract surgery on both eyes. It compares a new combination of eye drops and injections, including Triamcinolone Acetonide (a corticosteroid), with the usual care to determine if it better manages the surgery and recovery process. Individuals with cataracts in both eyes, who have well-controlled conditions like diabetes or a history of eye issues but no active problems in the past year, might be suitable candidates. The goal is to determine if the new treatment can improve outcomes and reduce complications after surgery. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage medical advancements.

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 those taking oral anti-inflammatory medications for systemic diseases, except for low-dose aspirin and ibuprofen for headaches.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that OMIDRIA, a combination of phenylephrine and ketorolac, is generally safe for use during cataract surgery. It helps maintain pupil dilation and reduces pain, with no major safety concerns. It is often used to prevent complications during surgery.

For triamcinolone acetonide, a type of steroid, studies have found it to be mostly safe for ocular use. However, some individuals might experience increased eye pressure, particularly those with glaucoma.

In summary, research has demonstrated the safety of both treatments, though some risks exist. Patients should consult their healthcare provider to determine if these treatments are appropriate for them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for cataract surgery, which typically involves patient-administered eye drops, the new treatment protocol being tested incorporates intraoperative and in-office administration of medications like triamcinolone acetonide and OMIDRIA. Researchers are excited because this approach could streamline the treatment process by reducing the reliance on patient compliance with post-op drops. The unique use of intraoperative triamcinolone acetonide aims to control inflammation more effectively during and after surgery, potentially leading to better outcomes and faster recovery times.

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

Research has shown that OMIDRIA, a combination of phenylephrine and ketorolac, aids during cataract surgery by keeping the pupil open wide, which is crucial for the procedure. Notably, 96% of patients maintain a pupil size of 6 mm or more when the new lens is inserted. This treatment also reduces the need for additional medications during surgery by 67.2%. In this trial, participants in the study arm will receive OMIDRIA along with subconjunctival triamcinolone acetonide, which is expected to further enhance surgical outcomes by reducing swelling. Together, these treatments aim to make cataract surgery safer and more effective. ^{2 4 6 7 8}

Who Is on the Research Team?

Paul Singh, MD

Principal Investigator

The Eye Centers of Racine & Kenosha

Are You a Good Fit for This Trial?

This trial is for patients scheduled for cataract surgery in both eyes. It's not clear what the specific inclusion or exclusion criteria are, but typically participants would need to be adults with a diagnosis of cataracts and no other major eye diseases.

Inclusion Criteria

I am willing and able to follow the study's requirements and visit schedule.

I am at high risk for surgery complications but have had no active disease or treatment in the last year.

Able to provide written informed consent prior to any study related procedure

Exclusion Criteria

Any prior ocular implant

Diagnosis of retinal thickening in the study eye within 12 months of enrollment

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative

Participants self-administer ketorolac and moxifloxacin drops before surgery

1 day

1 visit (in-person)

Surgery and Immediate Post-operative

Participants receive in-office drops and undergo cataract surgery

1 day

1 visit (in-person)

Post-operative Treatment

Participants self-administer ketorolac, prednisolone acetate, and moxifloxacin drops

1 month

Follow-up

Participants are monitored for inflammation and other outcomes

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone Acetonide

Trial Overview The study compares complication rates between two treatments during cataract surgery. One eye gets NSAID, OMIDRIA, and triamcinolone (Study Arm), while the other eye receives standard care (Control Arm). The assignment of each treatment to an eye is random.

How Is the Trial Designed?

Group I: Study Arm (OMIDRIA) Experimental Treatment 1 Intervention

* Pre-op, 1 drop ketorolac (0.5%) {Toradol}, 1 drop moxifloxacin (0.5%) {Avelox} * Prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Concl. of surgery while still in the OR: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) {Pred Forte} * Post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Intraoperative interventions: intracameral phenylephrine {Sudafed} 1.0%/ketorolac 0.3%, {OMIDRIA} intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10 mg/mL) {Kenalog}. In-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Rescue therapy will be allowed, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate (1%) QID (taper also at the discretion of the evaluating physician).

Group II: Control Arm (Standard of Care) Active Control 1 Intervention

Self-administration of: Ketorolac (0.5%) {Toradol} four times daily (QID) x 1 day and moxifloxacin (0.5%) {Avelox} drops three times daily (TID) x 1 day before SX. On the Day of SX, eyes will receive in-office drops administered by study staff according to the following: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to SX: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of SX while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) Pred Forte} * Any time in post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Eyes will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month. Prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.

Who Is Running the Clinical Trial?

Inder Paul Singh, M.D.

Lead Sponsor

Trials

1

Recruited

90+

The Eye Associates

Collaborator

Trials

3

Recruited

380+

Published Research Related to This Trial

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

Triamcinolone acetonide, at clinically relevant doses (200 microg/mL), was found to be toxic to retinal pigment epithelial (ARPE-19) and retinal neurosensory (R28) cells in vitro, reducing cell viability significantly after 24 hours of exposure.

The study indicated that while the vehicle used to suspend triamcinolone acetonide was nontoxic on its own, it may enhance the cytotoxic effects of the steroid, suggesting a need for caution in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity of triamcinolone acetonide on retinal neurosensory and pigment epithelial cells. Narayanan, R., Mungcal, JK., Kenney, MC., et al.[2013]

Triamcinolone acetonide (Kenalog) injections into the nasal turbinates have been successfully used in over 60,000 patients for treating allergic and vasomotor rhinitis, showing positive results without serious side effects.

The authors highlight the importance of preventing complications, such as intravascular injections that can affect the retinal circulation, by proposing specific methods to avoid this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. McCleve, D., Goldstein, J., Silver, S.[2019]

In a study of 31 eyes from 30 patients, subconjunctival injections of triamcinolone acetonide significantly improved visual acuity and reduced central macular thickness over 12 months, indicating its efficacy in treating uveitic macular edema.

The treatment was found to be safe, with no significant increase in intraocular pressure and only one cataract diagnosed, which occurred in an uninjected eye, suggesting minimal risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. Bleriot, A., Couret, C., Le Meur, G., et al.[2014]

A new method using a 5.0-microm porous membrane filter can effectively isolate triamcinolone acetonide particles from its commercial suspension, significantly reducing the preparation time for intravitreal use.

This method successfully eliminates 99.7% of benzyl alcohol and 88.1% of high-viscosity carboxymethylcellulose, which may enhance the therapeutic efficacy of triamcinolone by minimizing additives that could interfere with its action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating triamcinolone acetonide particles for intravitreal use with a porous membrane filter. Nishimura, A., Kobayashi, A., Segawa, Y., et al.[2019]

Citations

1. omidria.com omidria.com/

OMIDRIA® (phenylephrine and ketorolac) | Official HCP Website 96% · of OMIDRIA-treated patients had pupil diameter ≥6 mm at the start of lens implantation · 67.2% · reduction in use of PEDs during surgery · 21% · reduction in ...

2. crstoday.com crstoday.com/articles/improving-the-quality-of-cataract-surgery-outcomes-with-omidria-phenylephrine-and-ketorolac-intraocular-solution-1-0-3/improving-the-quality-of-cataract-surgery-outcomes-with-omidria-phenylephrine-and-ketorolac-intraocular-solution-1-0-3-2

Improving the Quality of Cataract Surgery Outcomes With ... Surgical time with OMIDRIA was significantly shorter at 8.1 minutes versus 9.4 minutes with epinephrine. OMIDRIA made a big difference.20. Reducing ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06681688

Study of Complication Rates in Cataract Surgery Patients ... Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide ...

4. omidria.com omidria.com/clinical-data

Clinical Data | OMIDRIA® (phenylephrine and ketorolac) 96% of OMIDRIA-treated patients had pupil diameter ≥6 mm at the start of lens implantation · Real-world evidence shows that OMIDRIA can benefit ALL patient types ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26703280/

Intracameral phenylephrine and ketorolac during cataract ... Phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40155503/

Optimizing pain management and pupil dilation in cataract ... Phenylephrine/ketorolac (OMIDRIA®) demonstrates superior efficacy in maintaining intraoperative mydriasis, reducing postoperative pain, and minimizing opioid ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000SumR.pdf

205388Orig1s000 Overall, the benefits outweigh the risks when Omidria is used during cataract surgery or intraocular lens replacement. • Recommendation for ...

8. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/0413e14a-9564-4aca-8b30-b5f4832ab4c9/download

Safety and Efficacy Data Supporting FDA Approval of ... Conclusions: Phenylephrine and ketorolac 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery. Postoperative pain levels were ...