UnknownPhase 4

Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

United States20 participantsStarted 2020-08-01

Plain-language summary

Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Been diagnosed with clinically significant cataract and CE/PCIOL has been planned * Bilateral cataract surgery with IOL has been planned * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form Exclusion Criteria: * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Obstructed nasolacrimal duct in the study eye(s) * Hypersensitivity to dexamethasone * Patients being treated with immunomodulating agents in the study eye(s) * History of prior ocular surgery, excluding Lasik or PRK * History of ocular inflammation or macular edema * Use of any systemic NSAIDs greater than 375 mg per day * Patients being treated with immunosuppressants and/or oral steroids * Patients with a corticosteroid implant (i.e. Ozurdex) * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-operative inflammation scores

Timeframe: Assessed on Days 1, 7, 30 for change

Post-op pain scores

Timeframe: Assessed on Days 1, 7, 30 for change

Trial details

NCT IDNCT04592081

SponsorKerry Assil, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-01

Contact for this trial

Kellie Burch

310-651-2392 kburch@assileye.com

View on ClinicalTrials.gov More Post-Surgical Ocular Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.