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Nonsteroidal Anti-Inflammatory Drug

Ketorolac for Cataracts

Phase < 1

Recruiting

Led By Eric Donnenfeld, MD

Research Sponsored by DHS Consulting

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing cataract surgery immediately followed by pars plana vitrectomy

Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters)

Must not have

Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)

Age < 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the day of surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the levels of Ketorolac in eye samples from patients having cataract and vitrectomy surgeries with or without a specific eye medication called OMIDRIA. Some patients will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include irritation or discomfort in the eye where Ketorolac is applied, potential allergic reactions, and temporary vision problems post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with a condition needing vitrectomy surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am under 18 years old.

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I have had a vitrectomy.

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I experienced complications during my cataract surgery.

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I have a tear in the back part of my eye's lens capsule.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the day of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the day of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and the day of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concentration of ketorolac in the vitreous humor

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: OMIDRIAActive Control1 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 KetorolacActive Control1 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.

0 / 7Eligibility criteria met