Comparing Dexamethasone Inserts to Standard Steroid Drops After Eye Surgery
Official title: A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)
Run by Vance Thompson Vision - MT · NCT04549935 · Data updated 2026-11-12
This study is testing whether a new eye insert can work better than regular steroid eye drops for patients recovering from eye surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Vance Thompson Vision - MT Academic / other |
| Locations | 1 site (Bozeman, Montana) |
| Status | Recruiting |
| Started | September 14, 2020 |
| Main results expected | August 27, 2021 |
| Study ends | August 27, 2021 |
| Registry record updated | September 16, 2020 |
| Trial ID | NCT04549935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 22 to 75 who are scheduled for bilateral RLE surgery and have a best-corrected visual acuity of 20/30 or better.
✕Probably not a fit
Patients with active ocular diseases, severe systemic conditions, or those with a history of ocular inflammation or macular edema may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the outcomes of patients undergoing bilateral refractive lens exchange (RLE) surgery by comparing the effectiveness of a dexamethasone intracanilicular insert (Dextenza) to standard topical steroid drops (prednisolone acetate). Patients will receive one treatment in each eye and will be monitored for post-operative inflammation and the risk of cystoid macular edema. Evaluations will occur on Day 1, Day 7, and one month post-surgery to assess patient preferences and outcomes. The study aims to determine which treatment method provides better results for patients.
Why it matters
Potential benefit: If successful, this study could lead to improved post-operative care and outcomes for patients undergoing eye surgery.
How similar studies have gone: Other studies have shown promising results with similar approaches, but this specific comparison of dexamethasone inserts versus topical drops is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Briana Parker
Bozeman, Montana, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Oncology care coordination program for Native American patients
This project will test whether a coordinated care and navigation program (C3PO) helps Native American adults newly diagnosed with cancer communicate with care teams and report better outcomes.
-
Family involvement in treatment decisions for very old ICU patients
This study observes how families and ICU teams communicate with patients 75 and older to see how family meetings affect planning and care.
-
Examining plaque characteristics in patients deferred from coronary intervention
This study is trying to see if certain types of plaque in the arteries can help predict heart problems in patients who were not treated with a heart procedure.
-
Using TENS units to reduce pain during IUD insertion
This study is testing if using TENS units can help reduce pain for women aged 12 to 50 during IUD insertion.
-
Helping elderly patients discuss their end-of-life care preferences
This study is trying to see if helping elderly patients talk about their end-of-life care wishes can lead to better care and satisfaction compared to standard practices.
-
Understanding Patient Choices in Rectal Cancer Treatment
This study is trying to understand what treatment options people with operable rectal cancer prefer and how their choices are influenced by their personal circumstances.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.