Trial Outcomes & Findings for DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (NCT NCT05620901)
NCT ID: NCT05620901
Last Updated: 2026-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Baseline, post-op days 1, 7, 28, and 45
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
Dextenza Arm
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
4
|
|
Overall Study
COMPLETED
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Dextenza Arm
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
Baseline characteristics by cohort
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.27 years
STANDARD_DEVIATION 2.37 • n=60 Participants
|
12.25 years
STANDARD_DEVIATION 2.36 • n=56 Participants
|
10.06 years
STANDARD_DEVIATION 2.37 • n=116 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
9 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
6 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=60 Participants
|
3 Participants
n=56 Participants
|
11 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
14 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
15 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-op days 1, 7, 28, and 45The 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.
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Pain as Measured by the FLACC Pain Scale
Post-op day 1
|
0 score on a scale
Standard Deviation 1.19
|
0 score on a scale
Standard Deviation 0
|
|
Pain as Measured by the FLACC Pain Scale
Post-op day 7
|
0 score on a scale
Standard Deviation 0.60
|
0 score on a scale
Standard Deviation 0
|
|
Pain as Measured by the FLACC Pain Scale
Post-op day 28
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Pain as Measured by the FLACC Pain Scale
Post-op day 45
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Pain as Measured by the FLACC Pain Scale
Baseline
|
0 score on a scale
Standard Deviation 1.42
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Up to post-op day 45Adverse events are addressed/ assessed at each visit
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to post-op day 45Population: Data not collected as no adverse events occurred.
Adverse events are addressed/ assessed at each visit
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, post-op days 1, 7, 28, and 45Inflammation 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.
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Ocular Inflammation (AC Cell Count)
Baseline
|
0 score on a scale
Standard Deviation 0.302
|
0 score on a scale
Standard Deviation 0
|
|
Ocular Inflammation (AC Cell Count)
Post-op day 1
|
0.5 score on a scale
Standard Deviation 0.778
|
0 score on a scale
Standard Deviation 0
|
|
Ocular Inflammation (AC Cell Count)
Post-op day 7
|
0.5 score on a scale
Standard Deviation 0.592
|
0 score on a scale
Standard Deviation 0
|
|
Ocular Inflammation (AC Cell Count)
Post-op day 28
|
0 score on a scale
Standard Deviation 0.158
|
0 score on a scale
Standard Deviation 0
|
|
Ocular Inflammation (AC Cell Count)
Post-op day 45
|
0 score on a scale
Standard Deviation 0.167
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Post-op days 1, 7, 28, and 45AC (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.
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Percentage of Participants With AC (Anterior Chamber) Cell
Post-op day 1
|
60 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With AC (Anterior Chamber) Cell
Post-op day 7
|
82 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With AC (Anterior Chamber) Cell
Post-op day 28
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With AC (Anterior Chamber) Cell
Post-op day 45
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: up to 45 days post-opPopulation: Participants with a nonzero FLACC score at a postoperative visit.
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.
Outcome measures
| Measure |
Dextenza Arm
n=5 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Number of Participants With Resolution of Pain
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-op days 1, 7, 28, and 45Intraocular pressure is assessed at each visit.
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Change in Absolute Intraocular Pressure (IOP)
Post-op day 1
|
0.0 mmHg
Interval -4.5 to 5.5
|
-5.0 mmHg
Interval -5.5 to -3.5
|
|
Change in Absolute Intraocular Pressure (IOP)
Post-op day 7
|
3.0 mmHg
Interval -1.5 to 6.0
|
-2.5 mmHg
Interval -3.5 to 0.8
|
|
Change in Absolute Intraocular Pressure (IOP)
Post-op day 28
|
2.0 mmHg
Interval -2.5 to 4.0
|
4.5 mmHg
Interval -0.3 to 8.0
|
|
Change in Absolute Intraocular Pressure (IOP)
Post-op day 45
|
-1.0 mmHg
Interval -4.0 to 3.0
|
2.0 mmHg
Interval -2.5 to 3.5
|
SECONDARY outcome
Timeframe: up to 45 days post-opLevel 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.
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Number of Participants With Rebound Inflammation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 45 days post-opSupplemental drops needed will be documented at each subsequent visit.
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 45 days post-opPopulation: Data not collected as no participants required supplemental drops.
Supplemental drops needed will be documented at each subsequent visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, post-op days 1, 7, 28, and 45Determined 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.
Outcome measures
| Measure |
Dextenza Arm
n=11 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline
Baseline to post-op day 1
|
0.34 logMAR
Interval 0.2 to 0.76
|
1.36 logMAR
Interval 1.28 to 1.53
|
|
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline
Baseline to post-op day 7
|
-0.08 logMAR
Interval -0.285 to 0.2
|
0.375 logMAR
Interval 0.33 to 0.57
|
|
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline
Baseline to post-op day 28
|
-0.25 logMAR
Interval -0.665 to 0.06
|
0 logMAR
Interval -0.07 to 0.14
|
|
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline
Baseline to post-op day 45
|
-0.50 logMAR
Interval -1.12 to -0.1
|
-0.09 logMAR
Interval -0.08 to -0.04
|
SECONDARY outcome
Timeframe: Day 45 post-opPopulation: Participants who completed the survey.
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".
Outcome measures
| Measure |
Dextenza Arm
n=9 Participants
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
|
Control Arm (Steroid Drops)
n=4 Participants
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) 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.
|
|---|---|---|
|
Caregivers Treatment Adherence
|
2.00 score on a scale
Standard Deviation 1.51
|
1.50 score on a scale
Standard Deviation 1.89
|
Adverse Events
Dextenza Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm (Steroid Drops)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place