Patient PreferenceVision and hearingDrugPhase 4
What this study is
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.
What's being tested
- Dextenza
Intervention · DRUG
Dextenza 0.4mg
- Topical Prednisolone
Intervention · DRUG
Standard of care topical drop treatment
Study details
- 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)
- Sponsor
- Vance Thompson Vision - MT
- Conditions
- Patient Preference · Patient Outcomes · Post-Operative Inflammation · Grade of Post-Operative Cystoid Macular Edema · Rate of Post-Operative Cystoid Macular Edema
- Enrolling
- 20 people
- Starts
- 2020-09-14
- Est. completion
- 2021-08-27
- Design
- Double-blind, randomized, crossover, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years – 75 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBriana Parker
Bozeman, Montana, United States
- Briana Parker · Contact406-599-5961briana.parker@vancethompsonvision.com
- Keeley Puls · Contact605 371-7075kpuls@vancethompsonvision.com
- Russell Swan, MD · Principal investigator
- Travis Whitt, OD · Sub-investigator
- Seirra Steiner, OD · Sub-investigator
Recruiting
Study team
Sponsor
Vance Thompson Vision - MT
Study ID The PRIME Study
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.