Combined Phacoemulsification and STREAMLINE Surgical System Canal of Schlemm Transluminal Dilation in Eyes of Hispanic Patients with Mild to Moderate Glaucoma

Figures & data

Table 1 Demographic and Baseline Glaucoma Status Data for the Study Sample (n=37*)

Parameter	Value
Age (yr), mean (SD)	66.0 (10.5)
Gender, n (%)
Male	6 (16.2)
Female	31 (83.8)
Ethnicity, n (%)
Hispanic	37 (100)
Operative eye, n (%)
Right	20 (54.1)
Left	17 (45.9)
Number of IOP-lowering medications, n (%)
1	12 (32.4)
2	10 (27.0)
3	15 (40.5)
Mean (SD) Visual field mean deviation	−4.66 (3.52)

Notes: *Patients completing 12 months = 35 (1 subject withdrew consent and 1 subject exited early due to an adverse event).

Table 2 Mean Intraocular Pressure (IOP) and Medication Use and Changes from Baseline at Each Study Time Point. Baseline for IOP Was After Medication Washout, While Baseline for Medications Was Before Washout

	Screening	Baseline	Day 1	Week 1	Month 1	Month 3	Month 6	Month 9	Month 12
Number of eyes	37	37	37	37	36	36	36	36	35
IOP (mmHg)
Mean (SD)	16.9 (3.2)	23.2 (2.3)	15.0 (3.9)	18.4 (6.5)	14.7 (2.3)	15.4 (2.1)	15.2 (2.4)	15.2 (2.4)	16.2 (2.2)
Mean (SD) change from baseline	–	–	8.2	4.8	8.5	7.8	8.0	8.0	7.0
Mean (SD) % change from baseline	–	–	48.5	28.2	36.5	33.4	34.3	34.4	30.2
Significance	–	–	<0.0001	0.0002	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001
Medications (n)
Mean (SD)	2.1 (0.9)	0 (0)	0.1 (0.3)	0.2 (0.6)	0.5 (0.9)	0.6 (1.0)	0.8 (1.0)	0.8 (1.0)	0.8 (1.0)
Mean (SD) change from baseline	–	–	2.0	1.9	1.6	1.5	1.3	1.2	1.3
Mean (SD) % change from baseline	–	–	97.4	92.3	74.6	70.6	63.9	59.9	60.5
Significance	–	–	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001

Abbreviations: IOP, intraocular pressure; SD, Standard Deviation.

Figure 1 Responder analysis of percent reduction in intraocular pressure at 12 months in all eyes and those unmedicated at month 12.

Figure 2 Endothelial cell density over time. Error bars represent standard deviation.

Table 3 Comparison of Outcomes in the Current Study Compared with Those Reported in Studies of Trabecular Meshwork Bypass Devices and Other Transluminal Dilation Procedures in Combination with Phacoemulsification

Procedure	Time Point (Months)	Baseline IOP	Mean IOP Reduction (%)	% Achieving ≥20% IOP Reduction	Mean Medication Reduction (%)	% Medication-Free
STREAMLINE transluminal dilation of the canal of Schlemm (current study)	12	23.2 mmHg*	30.2%	80%	60.5%	51.4%
iStent (1st generation)^Citation16	12	25.4 mmHg*	33.1%*	66%*	NR	85%
2 iStents (1st generation)^Citation17	12	27.3 mmHg*	18.7%*	13.3%*	37.4%	24%
iStent inject (2nd generation)^Citation18	24	24.8 mmHg*	31%*	78.5%*	75%	86.7%
Hydrus^Citation17	12–24	26.3–27.5 mmHg*	29.8%-35.7*	39.7%-80*	60.4–75%	46.6–72.9%
Hydrus^Citation19	24	26.3 mmHg*	35.7%*	80%*	75%	72.9%
Visco360^Citation20–22	12–18	22.0–24.6 mmHg	22–41%	87%	32–89%	32–86%
iTrack device^Citation23–30	12–48	18.1–23.6 mmHg	26–40%	78.4%	39–97%	25–80%

Note: *Unmedicated.

Abbreviation: IOP, intraocular pressure.

Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011;118:459–467. doi:10.1016/j.ophtha.2010.07.007

 PubMed Web of Science ®Google Scholar

Ahmed IIK, Fea A, Au L, et al. A prospective randomized trial comparing Hydrus and iStent microinvasive glaucoma surgery implants for standalone treatment of open-angle glaucoma: the COMPARE study. Ophthalmology. 2020;127:52–61. doi:10.1016/j.ophtha.2019.04.034

 PubMed Web of Science ®Google Scholar

Samuelson TW, Sarkisian SR Jr, Lubeck DM, et al. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract: two-year results. Ophthalmology. 2019;126:811–821. doi:10.1016/j.ophtha.2019.03.006

 PubMed Web of Science ®Google Scholar

Samuelson TW, Chang DF, Marquis R, et al. A schlemm canal microstent for intraocular pressure reduction in primary open-angle glaucoma and cataract: the HORIZON study. Ophthalmology. 2019;126:29–37. doi:10.1016/j.ophtha.2018.05.012

 PubMed Web of Science ®Google Scholar