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. 2018 Jan 31:12:255-262.
doi: 10.2147/OPTH.S152268. eCollection 2018.

Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes

L Jay Katz  1 , Carl Erb  2 , Amadeu Carceller Guillamet  3 , Antonio M Fea  4 , Lilit Voskanyan  5 , Jane Ellen Giamporcaro  6 , Dana M Hornbeak  6
Affiliations

Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes

L Jay Katz et al. Clin Ophthalmol. .

Abstract

Purpose: Evaluate long-term outcomes after one, two, or three trabecular micro-bypass stents implanted in a standalone procedure in eyes with open-angle glaucoma taking ocular hypotensive medication.

Patients and methods: Prospective randomized ongoing study of 119 subjects (109 with 42-month follow-up) with open-angle glaucoma, preoperative intraocular pressure (IOP) 18-30 mmHg on one to three glaucoma medications, and unmedicated (post-washout) IOP 22-38 mmHg. Subjects were randomized to receive one (n=38), two (n=41), or three (n=40) iStent trabecular micro-bypass stents in a standalone procedure. Postoperatively, IOP was measured with medication and annually following washout. Data included IOP, medications, gonioscopy, pachymetry, visual field, visual acuity, adverse events, and slit-lamp and fundus examinations.

Results: Preoperative mean medicated IOP was 19.8±1.3 mmHg on 1.71 medications in one-stent eyes, 20.1±1.6 mmHg on 1.76 medications in two-stent eyes, and 20.4±1.8 mmHg on 1.53 medications in three-stent eyes. Post-washout IOP prior to stent implantation was 25.0±1.2, 25.0±1.7, and 25.1±1.9 mmHg in the three groups, respectively. Postoperatively, Month 42 medicated IOP was 15.0±2.8, 15.7±1.0 and 14.8±1.3 mmHg in the three groups, and post-washout IOP (Months 36-37) was 17.4±0.9, 15.8±1.1 and 14.2±1.5 mmHg, respectively. IOP reduction ≥20% without medication was achieved in 89%, 90%, and 92% of one-, two-, and three-stent eyes, respectively, at Month 12; and in 61%, 91%, and 91% of eyes, respectively, at Month 42. The need for additional medication remained consistent at Months 12 and 42 in multi-stent eyes (four two-stent eyes and three three-stent eyes at both time points), whereas it increased in single-stent eyes (four eyes at Month 12 versus 18 eyes at Month 42). Safety parameters were favorable in all groups.

Conclusion: The standalone implantation of either single or multiple iStent® device(s) produced safe, clinically meaningful IOP and medication reductions through 42 months postoperatively, with incrementally greater and more sustained reductions in multi-stent eyes.

Keywords: iStent; microinvasive glaucoma surgery/MIGS; multiple; standalone; surgery.

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Conflict of interest statement

Disclosure LJK is a shareholder in Aerie Pharm., Glaukos, and Mati Ther, he received grant support from Allergan, Aerie Pharm., Mati Therapeutics, Diopsys, Heidelberg Eng., Alcon, and Zeiss; speaker honoraria from Alcon, Allergan, Bausch & Lomb, Aerie Pharm., and Glaukos; and a medical monitor consulting fee from Glaukos; he is a consultant to Allergan, Alcon, Glaukos (Chief Medical Officer), Aerie Pharm., Inotek, Mati Ther., Diopsys, and DSM Biomed. CE is a consultant to Alcon, Zeiss, OmniVision, and Visufarma, and received speaker honoraria from Alcon, Allergan, Bausch & Lomb, Novartis, Thea, Santen, Visufarma, Glaukos, and Zeiss. ACG received financial support from Glaukos for his work as an investigator in this study. AMF received financial support from Glaukos for his work as an investigator in this study. LV received financial support from Glaukos for her work as an investigator in this study. DMH and JEG are employees of Glaukos. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
iStent® trabecular micro-bypass. Notes: iStent®; Glaukos Corporation, San Clemente, CA, USA.
Figure 2
Figure 2
Mean IOP over time.a aNotes: Excludes data after cataract surgery. *M12–13 IOP includes M12 IOP of eyes taking 0 medications, plus M13 post-washout IOP of eyes that had been on medications. M24–25 and M36–37 IOP values are similar. Abbreviations: BL, baseline; IOP, intraocular pressure; M, month; SCR, screening.
Figure 3
Figure 3
Proportional analysis of postoperative IOP reduction ≥20% without medication at months 12 and 42.a aNote: Excludes data after cataract surgery. Abbreviations: IOP, intraocular pressure; M, month.
Figure 4
Figure 4
Time to addition of postoperative medication.a aNote: Excludes data after cataract surgery.
Figure 5
Figure 5
Proportional analysis of Month 42 best-corrected visual acuity.
See this image and copyright information in PMC

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