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

Trial Summary

What is the purpose of this trial?

This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.

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 triamcinolone acetonide generally safe for humans?

Triamcinolone acetonide has been used in many patients for conditions like asthma and nasal issues, with most experiencing no serious side effects. However, some people have reported side effects like weight gain, menstrual changes, high blood pressure, and swelling. ^{1 2 3 4 5}

Research Team

Paul Singh, MD

Principal Investigator

The Eye Centers of Racine & Kenosha

Eligibility Criteria

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.

Participants who do not meet the exclusion criteria may be enrolled.

Exclusion Criteria

I have glaucoma or react strongly to steroids.

Inability to provide informed consent

I use oral anti-inflammatory drugs for a condition, but not low-dose aspirin or ibuprofen for headaches.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

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]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Isolating triamcinolone acetonide particles for intravitreal use with a porous membrane filter. [2019]

4. France 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]. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Toxicity of triamcinolone acetonide on retinal neurosensory and pigment epithelial cells. [2013]