Research Article

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Table 2

Preoperative (baseline) and postoperative (for each follow-up visit) intraocular pressure (IOP), visual field mean deviation (MD), retinal nerve fiber layer (RNFL) thickness, and number of IOP-lowering medications required by the patient for XEN® 45 and XEN® 63 Gel Stent. Significance threshold was set at 0.05.

Measurement time pointN (number of eyes) XEN® 45/XEN® 63XEN® 45 mean value (range)XEN® 45 (vs. preop values)XEN® 63 Mean value (range)XEN® 63 (vs. preop values) (XEN® 45 vs. XEN® 63 values)

IOP (mmHg)
Preop (baseline)40/3418,02 ± 5,23 (10 to 40)19,00 ± 6,11 (11 to 36)0,459
12 months40/3413,81 ± 1,88 (9 to 18)≤0.00115,47 ± 2,45 (20 to 9)≤0.0010,002
24 months37/3014,80 ± 2,23 (11 to 21)≤0.00114,66 ± 2,45 (7 to 20)≤0.0010,827
36 months30/3014,62 ± 1,90 (12 to 18)≤0.00115,46 ± 2,48 (9 to 20)≤0.0010,191

Visual field-Mean deviation (MD)
Preop (baseline)40/309,97 ± 6,12 (0,6 to 23,10)10,42 ± 7,16 (-1,2 to 25,70)0,777
12 months32/308,98 ± 6,80 (0,0 to 24,60)0,6798,01 ± 5,56 (0,7 to 18,30)0,5490,606
24 months30/2910,57 ± 6,88 (1,3 to 22,80)0,3758,64 ± 5,94 (0,5 to 21,80)0,0670,353
36 months30/249,10 ± 5,52 (0,3 to 16,20)0,7007,59 ± 6,36 (-2,0 to 18,8)0,6850,437

Nerve fiber layer (microns)
Preop (baseline)39/3063,94 ± 11,42 (36 to 89)59,58 ± 14,91 (36 to 89)0,195
12 months20/3061,40 ± 10,13 (41 to 83)0,88162,50 ± 8,56 (44 to 79)0,5010,721
24 months20/2857,92 ± 8,15 (47 to 74)0,06462,15 ± 10,12 (50 to 92)0,2210,217
36 months20/2461,60 ± 10,09 (49 to 87)0,92464,81 ± 13,44 (41 to 94)0,3830,418

Number of glaucoma medications
Preop (baseline)40/341,60 ± 0,94 (0 to 3)1,64 ± 0,77 (0 to 3)0,854
12 months40/340,48 ± 0,78 (0 to 2)≤0.0010,41 ± 0,78 (0 to 2)≤0.0010,696
24 months35/300,41 ± 0,71 (0 to 2)≤0.0010,33 ± 0,71 (0 to 2)≤0.0010,672
36 months36/301,00 ± 0,87 (0 to 2)≤0.0010,46 ± 0,81 (0 to 2)≤0.0010,059