Three-year outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic population with primary open-angle glaucoma

Figures & data

Table 1 Subject accountability at 36 months postoperative

	n (%)
All operated eyes	168
Consistent cohort (eyes with 3-year data)	87 (51.8%) (49 Controlled/38 Uncontrolled)
Reasons unavailable at 3 years
Lost to follow-up	69 (41.1%)
Deceased (unrelated to study)	2 (1.2%)
Moved away	1 (0.6%)
Hospice care	1 (0.6%)
Followed by another doctor postoperatively	7 (4.2%)
Systemic steroids for non-ocular condition	1 (0.6%)

Abbreviation: n, number of eyes.

Table 2 Demographics and preoperative ocular characteristics, Consistent Cohort (n=87)

	Controlled Group n=49 eyes	Uncontrolled Group n=38 eyes
Age
Mean ± SD (years)	72.9±7.0	72.9±7.4
Range (years)	56–86	58–87
Race/Ethnicity^a
Hispanic n (%)	39 (79.6%)	27 (71.1%)
Caucasian n (%)	9 (18.4%)	9 (23.7%)
African American n (%)	1 (2.0%)	2 (5.3%)
Gender
Male n (%)	13 (26.5%)	17 (44.7%)
Female n (%)	36 (73.5%)	21 (55.3%)
Eye
OD n (%)	22 (44.9%)	17 (44.7%)
OS n (%)	27 (55.1%)	21 (55.3%)
Eyes with prior IOP-related ocular surgery^b Selective Laser Trabeculoplasty (SLT) Laser Peripheral Iridotomy (LPI) Trabeculectomy Ex-Press^® Glaucoma Filtration Device Penetrating keratoplasty (PKP)	6 (12.2%) 2 2 2 0 1 (7 surgeries total)	4 (10.5%) 3 1 0 1 0 (5 surgeries total)
IOP Mean ± SD (mmHg)	13.5±1.8	19.4±3.7
# Medications Mean ± SD	2.6±0.8	2.2±1.2
Peripapillary mean RNFL (µm) Mean ± SD	79.9±16.4	80.2±13.9
Visual field mean deviation Mean ± SD (dB)	−9.20±8.30	−8.08±6.72
BCVA % (n)  20/40 or better  20/50 or 20/60  20/70 or 20/80  20/100 or worse	22.2% (10/45)^c 53.3% (24/45) 11.1% (5/45) 13.3% (6/45)	30.3% (10/33)^d 42.4% (14/33) 18.2% (6/33) 9.1% (3/33)

Notes: ^aSelf-reported. If patients were of mixed race/ethnicity, they chose the one with which they most identified. ^bEyes could have more than one surgery. ^cNot recorded in 4 eyes at preoperative visit. ^dNot recorded in 5 eyes at preoperative visit.

Abbreviations: IOP, intraocular pressure; n, number of eyes; OD, right eye; OS, left eye; RNFL, retinal nerve fiber layer; BCVA, best-corrected visual acuity.

Table 3 Proportions of eyes with decreased, maintained, or increased medication burden versus preoperative, Controlled Group (n=49)

Medication change vs preop	Preop n (%)	Month 12 n (%)	Month 24 n (%)	Month 36 n (%)
Available at Visit	49	43	46	48
Percentage of eyes with decreased # meds from preop	N/A	38 (88.4%)	39 (84.8%)	45 (93.8%)
Percentage of eyes with no change in # meds from preop	N/A	5 (11.6%)	7 (15.2%)	3 (6.2%)
Percentage of eyes with increased # meds from preop	N/A	0 (0.0%)	0 (0.0%)	0 (0.0%)

Abbreviations: Preop, preoperative; n, number of eyes; med, medication; N/A, not applicable.

Figure 1 iStent^® Trabecular Micro-Bypass.

Figure 2 iStent^® implantation location.

Table 4 Proportions of eyes with decreased, maintained, or increased medication burden versus preoperative, Uncontrolled Group (n=38)

Medication change vs preop	Preop n (%)	Month 12 n (%)	Month 24 n (%)	Month 36 n (%)
Available at Visit	49	43	46	48
Percentage of eyes with decreased # meds from preop	N/A	17 (48.6%)	18 (50.0%)	25 (69.4%)
Percentage of eyes with no change in # meds from preop	N/A	17 (48.6%)	16 (44.4%)	9 (25.0%)
Percentage of eyes with increased # meds from preop	N/A	1 (2.9%)	2 (5.6%)	2 (5.6%)

Abbreviations: Preop, preoperative; n, number of eyes; med, medication; N/A, not applicable.

Figure 3 Mean medication burden and IOP through 36 months postoperative, Controlled Group (goal to reduce medications), Consistent Cohort (n=49).

Figure 4 Proportional analysis of medication burden through 36 months postoperative, Controlled Group, Consistent Cohort (n=49).

Figure 5 Mean IOP and medication burden through 36 months postoperative, Uncontrolled Group (goal to reduce IOP), Consistent Cohort (n=38).

Figure 6 Proportional analysis of medication burden, Uncontrolled Group, Consistent Cohort (n=38).

Table 5 Visual field mean deviation (MD) through 36 months postoperative, Eyes with available data at each visit

	Preop	Month 24	Month 36
Controlled Group Visual Field # eyes with measurement available at visit	43	42	37
Mean MD (dB)	−9.20	−8.93	−8.29
SD (dB)	8.30	8.71	8.07
p-value, comparison vs preoperative^a	N/A	0.212	0.801
Uncontrolled Group Visual Field # eyes with measurement available at visit	32	31	29
Mean MD (dB)	−8.08	−6.63	−8.15
SD (dB)	6.72	9.78	7.57
p-value, comparison vs preoperative^a	N/A	0.618	0.331

Notes: ^aPaired t-test. All p-values were not significant.

Abbreviations: MD, mean deviation; preop, preoperative.

Table 6 Mean peripapillary RNFL thickness through 36 months postoperative, Eyes with available data at each visit

	Preop	Month 24	Month 36
Controlled Group RNFL # eyes with measurement available at visit	37	41	38
Mean (µ)	79.93	78.46	80.32
SD (µ)	16.43	15.09	15.38
p-value, comparison vs preoperative^a	N/A	0.553	0.965
Uncontrolled Group RNFL # eyes with measurement available at visit	28	29	30
Mean (µ)	80.16	80.69	82.26
SD (µ)	13.94	12.78	13.46
p-value, comparison vs preoperative^a	N/A	0.329	0.251

Notes: ^aPaired t-test. All p-values were not significant.

Abbreviations: RNFL, retinal nerve fiber layer; preop, preoperative.