Interim Analysis of STREAMLINE^® Surgical System Clinical Outcomes in Eyes with Glaucoma

Figures & data

Table 1 Demographic and Baseline Glaucoma Status Data for the Study Sample (N=20)

Parameter	Value
Age (years), mean (SD)	64
Gender, n (%)
Male	3
Female	17
Ethnicity, n (%)
Hispanic	20 (100)
Operative eye, n (%)
Right	10 (50)
Left	10 (50)
Number of IOP-lowering medications, n (%)
1	6 (30)
2	8 (40)
3	6 (30)
Glaucoma severity, n (%)
Mild	8 (40)
Moderate	8 (40)
Severe	4 (20)

Table 2 Mean IOP and Changes from Baseline at Each Visit (N=20)

	Screening	Baseline	Day 1	Week 1	Month 1	Month 3	Month 6
Number of eyes	20	20	20	20	19	19	19
IOP (mmHg)
Mean (SD)	16.3 (3.6)	23.5 (2.5)	13.7 (3.2)	19.3 (7.8)	14.2 (2.3)	14.7 (2.1)	14.7 (2.4)
Mean (SD) change from baseline	–	–	9.8 (3.9)	4.2 (8.2)	9.3 (2.9)	8.8 (3.5)	8.8 (3.2)
Mean (SD) % change from baseline	–	–	41.1 (14.5)	17.0 (33.8)	39.2 (9.9)	36.8 (11.4)	36.9 (11.0)
Significance*	–	–	<0.001	0.035	<0.0001	<0.001	<0.001
Medications (n)
Mean (SD)	2.0 (0.8)	0 (0)	0 (0)	0.4 (0.8)	1.0 (1.2)	1.0 (1.1)	1.1 (1.1)
Mean (SD) change from baseline	–	–	2.0 (0.8)	1.6 (1.0)	1.0 (0.9)	1.0 (0.9)	0.9 (0.9)
Mean (SD) % change from baseline	–	–	100 (0)	81.7 (38.2)	57.9 (48.2)	56.1 (47.2)	49.1 (47.6)
Significance*	–	–	<0.001	<0.001	<0.001	<0.001	<0.001

Notes: *The p-value is for comparison of mean IOP at each time point to baseline. This is an ongoing study where data will be presented later. Data to be collected include IOP, IOP-lowering medications, and safety; and will be deidentified. These pooled results will be analyzed and shared in a manuscript at the one-year mark. No other study documents will be made available. This study complies with the Declaration of Helsinki and all subjects signed informed consent. The research was approved by Hospital Angeles Puebla ethics committee because it is an external committee. Clínica Láser does not have its own IRB.

Figure 1 Mean IOP at each time point.

Figure 2 Mean medication use at each time point.