This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days. The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care including topical antibiotics.
Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care including topical antibiotics.
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGTo assess control of inflammation following the vitreoretinal surgical procedure.
Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature \[SUN\] Working Group grading scheme at day 14
Time frame: day 14 following surgery
The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.
Pain following surgery will be measured using a scale from 0 to10 (0 = no pain, 10 = severe pain that prevents performing activities of daily living). Higher scores mean a worse outcome.
Time frame: days 1, 3, 7, 14, and 21 following surgery
Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.
Anterior segment will be assessed using a continuous variable (cells/mm3).
Time frame: days 1, 7, 14, and 21 following surgery
Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.
BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method.
Time frame: day 21 following surgery
% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.
Time frame: day 21 following surgery
% of patients receiving rescue treatment.
Time frame: days 1, 7, 14, and 21 following surgery
% of patients with postoperative management via telephone or electronic messaging
Time frame: day 21 following surgery
The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms.
Time frame: day 21 following surgery
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