Ketorolac for Cataracts

Recruiting in Palo Alto (17 mi)

Overseen by Eric Donnenfeld, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: DHS Consulting

Disqualifiers: Age < 18, Previous vitrectomy, others

No Placebo Group

Approved in 3 Jurisdictions

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.

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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.

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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.

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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.

I am 18 years old or older.

Able to provide informed consent

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

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ophthalmic Consultants of Long Island Westbury, NY

Who Is Running the Clinical Trial?

DHS Consulting Lead Sponsor

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] To investigate the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution (Acular; Allergan, Inc, Irvine, California) in the treatment of moderate to severe anterior segment inflammation developing after unilateral cataract surgery with intraocular lens implantation.

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] To compare the clinical, subjective, and objective outcomes of the use of 2 topical nonsteroidal antiinflammatory drugs--ketorolac tromethamine LS 0.4% (Acular) and nepafenac 0.1% (Nevanac)--in patients having cataract surgery.

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

The effect of topical ketorolac tromethamine on macular thickening after phacoemulsification in diabetic patients. [2023] To determine the effect of ketorolac tromethamine 0.5% in preventing post-phacoemulsification macular thickening. This randomized clinical trial. patients randomized 1:1 to receive either topical ketorolac three times a day or a placebo.

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

Topical 0.5% ketorolac vs 0.03% flurbiprofen for inhibition of miosis during cataract surgery. [2019] To compare the effects of topical 0.5% ketorolac tromethamine ophthalmic solution (Acular, Allergen Pharmaceuticals, Irvine, Calif) with topical 0.03% flurbiprofen sodium ophthalmic solution (Ocufen, Allergen Pharmaceuticals) on the inhibition of surgically induced miosis during phacoemulsification cataract surgery.

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

Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. [2019] To report a case of corneal ulceration and perforation after PRK connected with high doses of ketorolac tromethamine (Acula).

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

Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group. [2022] The analgesic efficacy and safety of topical ketorolac tromethamine 0.5% ophthalmic solution (Acular) in photorefractive keratectomy was compared to its vehicle.

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] To evaluate the efficacy and safety of twice-daily, preservative-free ketorolac 0.45% (Acuvail; Allergan, Inc, Irvine, California, USA) administration for treatment of inflammation and pain after cataract surgery.