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)
Who is this study for? Patients with Post-Operative Cystoid Macular Edema
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: t
View:
• 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
Locations
United States
Montana
Briana Parker
RECRUITING
Bozeman
Time Frame
Start Date: 2020-09-14
Estimated Completion Date: 2021-08-27
Participants
Target number of participants: 20
Treatments
Active_comparator: Group A Dextenza
Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.
Active_comparator: Group B Topical Prednisolone
Drug: Topical Prednisolone Standard of care topical drop treatment
Related Therapeutic Areas
Sponsors
Leads: Vance Thompson Vision - MT