Ketorolac for Cataracts

Overseen By Eric Donnenfeld, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: DHS Consulting

Disqualifiers: Age < 18, Previous vitrectomy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Ketorolac, an anti-inflammatory medication, in patients undergoing both cataract surgery and pars plana vitrectomy. Researchers aim to compare Ketorolac levels when administered as an eye drop versus as part of a special solution used during surgery. The study targets adults with cataracts and specific eye conditions, such as an epiretinal membrane or macular hole. Participants must be willing to follow all study procedures and not participate in another trial. As an Early Phase 1 trial, this research seeks to understand how Ketorolac functions in people, offering participants the opportunity to contribute to groundbreaking medical insights.

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.

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. Most patients experience no serious side effects. Studies tracking its use for up to 90 days post-surgery found that the benefits outweigh the risks.

For ketorolac tromethamine 0.5% eye drops, research indicates they are as safe as a placebo. They do not significantly affect vision or eye pressure, nor do they cause more side effects than a non-active treatment.

Both OMIDRIA and ketorolac eye drops have been well-tolerated in past research, suggesting they are likely safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for cataracts because they offer innovative approaches to managing inflammation and maintaining pupil size during surgery. Unlike standard cataract surgery treatments that typically involve separate medications for inflammation and pupil dilation, OMIDRIA combines phenylephrine and ketorolac into a single solution. This dual-action approach could streamline the surgical process by minimizing the need for multiple medications. Meanwhile, topical ketorolac is already known for its anti-inflammatory properties and is being explored for its effectiveness in reducing post-surgical inflammation and ocular itching. These treatments potentially enhance patient comfort and surgical outcomes, making them promising options for cataract management.

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

In this trial, participants will receive either OMIDRIA or topical ketorolac in separate treatment arms. Research has shown that OMIDRIA, which contains phenylephrine and ketorolac, helps maintain pupil dilation during cataract surgery. Specifically, 96% of patients who received OMIDRIA had a pupil size of 6 mm or more when the lens was implanted. This treatment also reduces the need for other pain medications during surgery by 67.2% and speeds up the procedure. Conversely, ketorolac eye drops effectively reduce inflammation and pain after cataract surgery. Studies have found that they significantly ease eye inflammation compared to a placebo (a treatment with no active ingredients). Both treatments offer proven benefits in managing inflammation and ensuring patient comfort during and after cataract procedures. ^{1 3 4 5 6}

Who Is on the Research Team?

Eric Donnenfeld, MD

Principal Investigator

Ophthalmic Consultants of Long Island

Are You a Good Fit for This Trial?

This trial is for patients who are scheduled to undergo combined cataract and pars plana vitrectomy surgeries. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed requirements.

Inclusion Criteria

I am having cataract surgery followed by a specific eye surgery.

Able to provide informed consent

Willing and able to comply with all study procedures

Exclusion Criteria

I am having cataract surgery or a vitrectomy but not both at the same time.

Participating in another clinical trial

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Sample Collection

Patients undergo combined cataract and pars plana vitrectomy surgeries. Aqueous and vitreous samples are taken intraoperatively for analysis of ketorolac concentrations.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac Tromethamine
• OMIDRIA

Trial Overview The trial is testing Ketorolac levels in eye fluids during cataract/vitrectomy surgeries. One group will receive OMIDRIA (phenylephrine/ketorolac mix) inside the eye, while another gets topical ketorolac drops before surgery.

How Is the Trial Designed?

Group I: OMIDRIA Active Control 1 Intervention

OMIDRIA is a combination product containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial. Once the 4mL of OMIDRIA is diluted in 500 mL of ophthalmic irrigation solution, the resulting solution is intended to be used as needed during cataract surgery or intraocular lens replacement.

Group II: Topical Ketorolac Active Control 1 Intervention

Topical ketorolac tromethamine 0.5% is a nonsteroidal anti-inflammatory drug. It is FDA-approved for the treatment of inflammation following cataract surgery and relief of ocular itching due to seasonal allergic conjunctivitis.

Ketorolac Tromethamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Menstrual disorders
• Headaches

Approved in European Union as Ketorolac for:

• Moderate to severe pain
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Menstrual disorders
• Headaches

Approved in Canada as Ketorolac for:

• Moderate to severe pain
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Menstrual disorders
• Headaches

Who Is Running the Clinical Trial?

DHS Consulting

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

A case study of a 31-year-old man revealed that excessive use of ketorolac tromethamine (Acula) after PRK led to corneal ulceration and perforation, necessitating surgical intervention.

The findings highlight the importance of proper patient education regarding the use of topical NSAIDs post-surgery to prevent complications like corneal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. Mian, SI., Gupta, A., Pineda, R.[2019]

In a study of 183 patients undergoing cataract surgery, ketorolac tromethamine (Acular) was found to significantly improve patient satisfaction, compliance, and postoperative pain control compared to nepafenac (Nevanac).

While both medications showed similar visual outcomes and inflammation levels, the nepafenac group had a higher incidence of posterior capsule opacification, indicating a potential safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac tromethamine LS 0.4% versus nepafenac 0.1% in patients having cataract surgery. Prospective randomized double-masked clinical trial. Duong, HV., Westfield, KC., Chalkley, TH.[2013]

In a study of 118 patients undergoing cataract surgery, topical 0.5% ketorolac was found to be more effective than 0.03% flurbiprofen in preventing miosis (pupil constriction) during the procedure.

Ketorolac treatment resulted in a consistently larger pupillary diameter and more stable mydriasis (pupil dilation) throughout the surgery, indicating its efficacy as a mydriatic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical 0.5% ketorolac vs 0.03% flurbiprofen for inhibition of miosis during cataract surgery. Solomon, KD., Turkalj, JW., Whiteside, SB., et al.[2019]

In a study involving 511 cataract surgery patients, twice-daily administration of preservative-free ketorolac 0.45% significantly reduced inflammation, with 52.5% of patients achieving a summed ocular inflammation score of 0 by day 14, compared to only 26.5% in the vehicle group (P < .001).

Ketorolac also effectively alleviated pain, with 72.4% of patients reporting no pain on postoperative day 1, and a median time to pain resolution of 1 day, compared to 2 days for the vehicle group (P < .001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Donnenfeld, ED., Nichamin, LD., Hardten, DR., et al.[2013]

In a study involving 101 diabetic patients undergoing cataract surgery, topical ketorolac tromethamine 0.5% did not prevent post-surgery macular thickening, as there was no significant difference in central macular thickness between the ketorolac and placebo groups at any follow-up time point.

Both groups showed significant improvement in best corrected visual acuity after surgery, but the ketorolac treatment did not provide additional benefits in preventing macular thickening compared to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of topical ketorolac tromethamine on macular thickening after phacoemulsification in diabetic patients. Mohammad-Rabei, H., Sabbaghi, H., Emamverdi, M., et al.[2023]

In a study involving 200 patients undergoing photorefractive keratectomy, topical ketorolac tromethamine 0.5% was found to provide significantly greater pain relief compared to its vehicle, with patients experiencing less pain intensity and a longer time before needing additional pain medication.

The ketorolac group also reported fewer side effects, such as sleep difficulties and ocular discomfort, and overall, the treatment was deemed safe with minimal adverse events, indicating its efficacy and safety for post-surgery pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group. Rajpal, RK., Cooperman, BB.[2022]

In a multicenter study involving patients with moderate to severe inflammation after cataract surgery, ketorolac tromethamine 0.5% was significantly more effective than a placebo in reducing inflammation and associated symptoms like pain and photophobia.

The treatment was found to be safe, with no significant differences in visual acuity or adverse events compared to the placebo, indicating that ketorolac is a reliable option for managing post-surgical inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial. Heier, J., Cheetham, JK., Degryse, R., et al.[2019]

Citations

1. 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 ...

2. rayner.com rayner.com/global/rayner-completes-pivotal-dropless-cataract-surgery-study-with-omidria/

Rayner completes pivotal dropless cataract surgery study ... Notably, an overwhelming 90% of patients preferred the OMIDRIA regimen compared to 42% for standard eye drops. Interim study results were ...

3. 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 ...

4. 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 ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5029911/

Patient considerations in cataract surgery – the role ... Safety data from the phenylephrine/ketorolac combination have been collected until postoperative day 90 in published clinical trials,, ...