The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.
The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/laser to receive either: 1. Treatment Arm: Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively, or 2. Control Arm: Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28. Each treatment group (surgery or laser) will include 15 patients total, 10 receiving Dextenza and 5 receiving the control drug. Drops for dilation and antibiotic coverage will be used as clinically indicated in all groups throughout the study period. Follow up will occur at post-op day 1, 7, 28/30 and 45 ( +/- three days for all post-operative timepoints).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
To treat perioperative ocular inflammation and pain;
Duke Eye Center
Durham, North Carolina, United States
Pain as Measured by the FLACC Pain Scale
The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.
Time frame: Baseline, post-op days 1, 7, 28, and 45
Number of Participants With Adverse Events
Adverse events are addressed/ assessed at each visit
Time frame: Up to post-op day 45
Severity of Adverse Events
Adverse events are addressed/ assessed at each visit
Time frame: Up to post-op day 45
Ocular Inflammation (AC Cell Count)
Inflammation is evaluated at each visit during the slit lamp and fundus exam as measured by the ocular inflammation grading scale, which ranges from 0 to 4. A higher score indicates greater inflammation.
Time frame: Baseline, post-op days 1, 7, 28, and 45
Percentage of Participants With AC (Anterior Chamber) Cell
AC (Anterior Chamber) cell is evaluated during slit lamp and fundus exams during each post-op visit. Resolution defined as AC cell measured at 0 or 0.5 (trace) after surgery.
Time frame: Post-op days 1, 7, 28, and 45
Number of Participants With Resolution of Pain
This will be measured by using the FLACC Pain Rating Scale. The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale comprised of five behavioral indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10, where a higher score indicates greater pain. Resolution of pain is defined as having a nonzero FLACC score at a postoperative visit and a FLACC score of 0 at a following visit.
Time frame: up to 45 days post-op
Change in Absolute Intraocular Pressure (IOP)
Intraocular pressure is assessed at each visit.
Time frame: Post-op days 1, 7, 28, and 45
Number of Participants With Rebound Inflammation
Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams. Rebound inflammation is defined as recurrent AC (Anterior Chamber) cell \> 0 or .5 (trace) after initial resolution.
Time frame: up to 45 days post-op
Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops
Supplemental drops needed will be documented at each subsequent visit.
Time frame: up to 45 days post-op
Number of Supplemental Drops Needed in Treatment Participants
Supplemental drops needed will be documented at each subsequent visit.
Time frame: up to 45 days post-op
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline
Determined by using either ETDRS (Early Treatment Diabetic Retinopathy Study) or HOTV chart (uses the letters H, O, T, and V) testing depending on age. Visual Acuities were converted to logMAR scores for statistical analyses.
Time frame: baseline, post-op days 1, 7, 28, and 45
Caregivers Treatment Adherence
Documented with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family. Reported on a Likert scale of 1 to 5, with 1 being strongly disagree and 5 being strongly agree to "I sometimes forget to administer my child's eye drops".
Time frame: Day 45 post-op
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