Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication

Figures & data

Figure 1 iStent inject^® trabecular micro-bypass stent system: stents and injector.

Table 1 Demographic and Preoperative Ocular Characteristics

		57 Eyes of 57 Subjects
Gender Male/Female		30/27
Race	% Caucasian	100% (n=57)
Age (years)	Mean ± SD	65.3 ± 9.0
C:D ratio	Mean ± SD	0.7 ± 0.1
Medicated IOP (mmHg)	Mean ± SD	19.5 ± 1.5
Preoperative # medications	Mean ± SD	1 ± 0
Medication classes	% of eyes (n)
Prostaglandin		86% (n=49)
Beta-blocker		7% (n=4)
Carbonic anhydrase inhibitor		7% (n=4)
Unmedicated IOP (mmHg)	Mean ± SD	24.4 ± 1.3
Glaucoma severity (available in 56 eyes)^a	n (%)
Mild		5 (8.9%)
Moderate		15 (26.8%)
Severe		36 (64.3%)

Notes: ^aSeverity according to the Hodapp Parrish Anderson (HPA) glaucoma severity scale (Mild: mean deviation (MD) no worse than −6 dB; Moderate: MD worse than −6 dB but no worse than −12 dB; Severe: MD worse than −12 dB). Adapted from Lindstrom R, Lewis R, Hornbeak DM, et al. Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up. Adv Ther. 2016;33(11):2082-90.³⁶ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/).

Figure 2 Mean intraocular pressure through 48 months postoperative.^a,b

Notes: ^aVertical bars represent standard deviation. ^bEyes with secondary surgery or addition of medication were counted as non-responders, and their subsequent IOP data were excluded from mean IOP calculation. ^cUnmedicated/Post-washout. A 1-month medication washout was completed preoperatively.

Abbreviations: SCR, Screening; BL, Baseline; M, Month; IOP, intraocular pressure; Preop, preoperative; Med, medication.

Figure 3 Proportional Analysis of Medication-Free IOP and IOP Reduction at 12 and 48 Months Postoperative (n=57 for each category at both time points).^a

Note: ^aEyes with secondary surgery or addition of medication were counted as non-responders.

Abbreviations: IOP, intraocular pressure; SCR, Screening; BL, Baseline; M, Month; Preop, preoperative; Med, medication.

Table 2 Postoperative Ocular Adverse Events Through Month 48

Intraoperative Adverse Events
None
Postoperative Ocular Adverse Events in 3 Eyes
Case 1:
IOP elevation and BCVA loss >1 line at M32; was prescribed medication but returned with high IOP 1 week later and underwent secondary surgical intervention (trabeculectomy). IOP 18 mmHg preoperatively, 32 mmHg at M32, 12.3 mmHg at M36 (post-trabeculectomy), 11.3 mmHg at M48 BCVA 20/20 preoperatively, 20/40 at M32, 20/40 at M36 (post-trabeculectomy) and at M48 AE reported “definitely unrelated” to study treatment. Status “recovered.”
Case 2:
BCVA loss >1 line at M36 due to cataract progression. BCVA = 20/25 preoperatively, 20/40 at M36 and at M48 AE reported “definitely unrelated” to study treatment. Status “ongoing” (no cataract surgery as of M48).
Case 3:
BCVA loss >1 line at M12 due to cataract progression. BCVA = 20/100 preoperatively, 20/222 at M12 and at M48. AE reported “definitely unrelated” to study treatment. Status “ongoing” (no cataract surgery as of M48).

Table 3 Preoperative and Month 48 Best-Corrected Visual Acuity, Cup-to-Disc Ratio, Visual Field, and Central Corneal Thickness

		Screening (n=57)	Month 48 (n=57)
BCVA^a
20/25 or better	n (%)	41 (72%)	39 (68%)
20/40 or better	n (%)	53 (93%)	53 (93%)
20/100 or better	n (%)	57 (100%)	56 (98%)
C:D ratio^b	Mean (SD)	0.7 (0.1)	0.7 (0.1)
Visual field^b
Mean deviation (dB)	Mean (SD)	−4.9 (5.3)	−5.0 (6.2)
Pattern standard deviation (dB)	Mean (SD)	3.3 (2.4)	3.1 (2.6)
Central corneal thickness (µm)^b	Mean (SD)	544.9 (30.3)	544.7 (30.2)

Notes: ^aMeasured at screening and at every postoperative visit. ^bMeasured at screening and at every postoperative visit from 6 months onward.

Abbreviations: BCVA, best-corrected visual acuity; C:D, cup-to-disc.

Lindstrom R, Lewis R, Hornbeak DM, et al. Outcomes following implantation of two second-generation trabecular micro-bypass stents in patients with open-angle glaucoma on one medication: 18-month follow-up. Adv Ther. 2016;33(11):2082–2090. doi:10.1007/s12325-016-0420-8

 Web of Science ®Google Scholar