Briana Parker
Bozeman, Montana, 59718, United States
Location status: Recruiting
Location contact
Briana Parker
CONTACT
Keeley Puls
CONTACT
Russell Swan, MD
PRINCIPAL_INVESTIGATOR
Seirra Steiner, OD
SUB_INVESTIGATOR
Travis Whitt, OD
SUB_INVESTIGATOR
NCT Number: NCT04549935
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.
Interested in participating?
Request Info22 year–75 year
All sexes
Interventional
Phase 4
Bozeman, Montana, 59718, United States
Location status: Recruiting
Briana Parker
CONTACT
Keeley Puls
CONTACT
Russell Swan, MD
PRINCIPAL_INVESTIGATOR
Seirra Steiner, OD
SUB_INVESTIGATOR
Travis Whitt, OD
SUB_INVESTIGATOR
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dextenza 0.4mg
Standard of care topical drop treatment
Time frame: Through Month 1
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)
Time frame: Through Month 1
Measured by OCT (Optical Coherence Tomography )
Time frame: Through Month 1
Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
Time frame: Through Month 1
measured by OCT (Optical Coherence Tomography)
Time frame: Through Month 1
measured by OCT (Optical Coherence Tomography)
Time frame: Through Month 1
measured by SUN Working Group Grading Scheme
Time frame: Through Month 1
measured by ETDRS chart a 4m
Time frame: Through Month 1
measured by ETDRS chart a 4m
Vance Thompson Vision - MT
Other
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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