Dexamethasone Sustained-Release Intracanalicular Insert for Control of Postoperative Inflammation After Pars Plana Vitrectomy

Figures & data

Table 1 Baseline Demographics, Diagnoses, and Surgical Procedures for Study Subjects

	Study Group (n=23)	Control Group (n=23)
Age (years), mean (SD)	69.0 (10.4)	66.4 (9.3)
Gender, n (%)
Male	12 (52)	13 (57)
Female	11 (48)	10 (43)
Ethnicity
Caucasian	17 (74)	16 (70)
Hispanic or Latino	3 (13)	3 (13)
African American	2 (9)	3 (13)
Asian	1 (4)	2 (9)
Surgical Diagnosis, n (%)
Epiretinal Membrane	11 (48)	11 (48)
Macular Hole	3 (13)	3 (13)
Retinal Detachment	3 (13)	3 (13)
Vitreous Hemorrhage	3 (13)	3 (13)
Retained Silicone Oil	2 (9)	2 (9)
Vitreomacular Traction	1 (4)	1 (4)
Procedure Performed, n (%)
Pars plana vitrectomy	18 (78)	18 (78)
Combined phaco-vitrectomy	5 (22)	5 (22)

Notes: Study Group refers to the Dexamethasone Intracanalicular Insert (DII) Group and Control Group refers to the Standard Topical Steroid Therapy Group.

Abbreviation: SD, standard deviation.

Table 2 Primary and Secondary Outcomes for Study Subjects

	Study Group (n=23)	Control Group (n=23)	p-value^a
Anterior Chamber Cell Clearance
Day 1 # (%)	3 (13%)	2 (9%)	0.01*
Day 7 # (%)	15 (65%)	8 (35%)
Day 30 # (%)	0 (0%)	0 (0%)
IOP, mmHg
Baseline Mean (Range)	12.9 (5–20)	15.3 (9–22)	0.3
Day 7 Mean (Range)	10.5 (5–18)	10.7 (5–32)
Day 30 Mean (Range)	13.1 (5–23)	13.6 (6–23)
Mean ∆ From Baseline (Range)	0.2 (−4 to +8)	−1.7 (−5 to +10)
IOP >25 mmHg # (%)	0 (0%)	2 (9%)
OCT CFT, microns
Baseline Mean (Range)	390.0 (237–641)	356.0 (250–527)	0.3
Day 30 Mean (Range)	292.5 (220–405)	296.8 (220–412)
Mean Change From Baseline	−97.5 (−289 to +9)	−49.5 (−140 to +92)
Cystoid Macular Edema # (%)	1 (4%)	3 (13%)

Notes: Study Group refers to the Dexamethasone Intracanalicular Insert (DII) Group and Control Group refers to the Standard Topical Steroid Therapy Group; ^achi-square analysis was employed to compare the groups; *Statistically significant (p≤0.05).

Abbreviations: #, absolute number of subjects; %, percent of subjects in group; IOP, intraocular pressure; mmHg, millimeters of mercury; ∆, change; OCT CFT, optical coherence tomography central foveal thickness.