Comparing Dexamethasone Inserts to Standard Steroid Drops After Eye Surgery
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)
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 |
| Enrollment | 20 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Vance Thompson Vision - MT Academic / other |
| Locations | 1 site (Bozeman, Montana) |
| Trial ID | NCT04549935 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with similar approaches, but this specific comparison of dexamethasone inserts versus topical drops is relatively novel.
Eligibility criteria
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 this trial is running
Bozeman, Montana
- Briana Parker — Bozeman, Montana, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.