The PRIME Study: A Randomized, Controlled, Prospective Study
Recruiting
Phase 4Interventional Study
Patient PreferencePatient OutcomesPost-Operative InflammationGrade of Post-Operative Cystoid Macular EdemaRate of Post-Operative Cystoid Macular Edema
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Vance Thompson Vision - MT · Other
Who this trial is looking for
This trial is looking for adults planning to have eye surgery in both eyes. Participants will compare a special eye insert with standard eye drops to see which works better and what patients prefer.
Are You a Good Fit for This Trial?
Must not be takingSystemic corticosteroidsNSAIDs greater than 1200 mg/day
Rules you outCorneal pathology
You may be able to join if
I am an adult scheduled for surgery on both eyes.
I have good vision (20/30 or better).
I can attend clinic visits for the study.
I can sign the consent form.
You may not be able to join if
I am under 22 or over 75 years old.
I am pregnant or could be pregnant.
I have an active eye infection.
I am currently using immunosuppressive treatment.
I am allergic to Dexamethasone.
I have a history of eye inflammation or swelling.
I cannot receive an antibiotic during surgery.
I have a severe eye condition that the doctor thinks is unsafe for the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form
Exclusion Criteria:
* Patients under the age of 22 or…
Inclusion Criteria:
* Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form
Exclusion Criteria:
* Patients under the age of 22 or above the age of 75
* Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
* Paitents with know hypersensitivity to Dexamethasone
* Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
* Patients with a history of ocular inflammation or macular edema
* Patients with allergy or inability to receive intracameral antibiotic
* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
* Patient with a corticosteriod implant (i.e. Ozurdex).
* Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
Contacts
No contact information available.
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