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

Trial Summary

What is the purpose of this trial?

This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.

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 data supports the effectiveness of the drug Ketorolac Tromethamine for cataract treatment?

Research shows that Ketorolac Tromethamine, used as an eye drop, is effective in reducing inflammation after cataract surgery and preventing macular thickening (swelling at the back of the eye) in diabetic patients. It has also been compared favorably to other anti-inflammatory drugs for use during cataract surgery. ^{1 2 3 4 5}

Is ketorolac safe for use in humans?

Ketorolac has been studied for safety in various eye conditions, including after cataract surgery, and is generally considered safe when used as directed. However, there have been reports of serious side effects like corneal ulceration (a sore on the eye's surface) and perforation (a hole in the eye) with high doses, so it's important to follow medical guidance. ^{1 2 4 5 6}

What makes ketorolac tromethamine unique for treating cataracts?

Ketorolac tromethamine is unique for cataract treatment because it is a nonsteroidal anti-inflammatory drug (NSAID) that can be administered as an eye drop to reduce inflammation and pain after cataract surgery, offering an alternative to steroid-based treatments. ^{1 2 3 5 7}

Research Team

Eric Donnenfeld, MD

Principal Investigator

Ophthalmic Consultants of Long Island

Eligibility Criteria

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.

I am under 18 years old.

Participating in another clinical trial

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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 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]

References

1. United States 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. [2019]

2. United States 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. [2013]

3. England pubmed.ncbi.nlm.nih.gov

The effect of topical ketorolac tromethamine on macular thickening after phacoemulsification in diabetic patients. [2023]

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

Topical 0.5% ketorolac vs 0.03% flurbiprofen for inhibition of miosis during cataract surgery. [2019]

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

Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. [2019]

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

Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group. [2022]

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

Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. [2013]