One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study

Colin I Clement; Frank Howes; Alexandros S Ioannidis; Michael Shiu; David Manning

doi:10.2147/OPTH.S187272

One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study

Clin Ophthalmol. 2019 Mar 13:13:491-499. doi: 10.2147/OPTH.S187272. eCollection 2019.

Authors

Colin I Clement^{1

2

3

4}, Frank Howes⁵, Alexandros S Ioannidis⁶, Michael Shiu⁷, David Manning⁸

Affiliations

¹ Eye Associates, Sydney, NSW, Australia, colinandkylie@me.com.
² Fairfield Eye Surgery, Fairfield, NSW, Australia, colinandkylie@me.com.
³ Glaucoma Unit, Sydney Eye Hospital, Sydney, NSW, Australia, colinandkylie@me.com.
⁴ Discipline of Ophthalmology, The University of Sydney, Sydney, NSW, Australia, colinandkylie@me.com.
⁵ Eye & Laser Centre Gold Coast, Southport, QLD, Australia.
⁶ Vision Eye Institute, Melbourne, VIC, Australia.
⁷ Laser Sight Laser Cataract & Lens Specialists, Sydney, NSW, Australia.
⁸ Hunter Cataract & Eye Centre, Sydney, NSW, Australia.

Abstract

Purpose: To assess the utility and safety of implanting two second-generation trabecular micro-bypass stents following cataract surgery in eyes with mild to advanced glaucoma or ocular hypertension (OHT).

Patients and methods: Retrospective study of iStent^®inject trabecular micro-bypass implantation with cataract surgery by five surgeons at five sites in Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle, appositional angle-closure, or pseudoexfoliative glaucoma) or OHT and cataract requiring surgery. Effectiveness measures included intraocular pressure (IOP); medication burden; and proportions of eyes with no medications, ≥2 medications, stable or decreased medications vs preoperative, and IOP ≤18 mmHg. Safety measures included visual acuity, cup-to-disc ratio (CDR), visual field (VF), complications, adverse events, and secondary surgical interventions. Patients have been followed for 12 months, and follow-up is ongoing.

Results: Of the 290 total eyes that underwent surgery, 165 eyes had 12-month outcomes at the time of data collection and are included in this report. In these eyes, mean Month 12 IOP reduced by 23.2% from 18.27±5.41 mmHg preoperatively to 14.04±2.98 mmHg (P<0.001), with 95.8% of eyes achieving Month 12 IOP of ≤18 mmHg vs 60.6% preoperatively. Mean number of medications at 12 months decreased by 71.5%, 0.47±0.95 vs 1.65±1.28 preoperatively; 76.4% of eyes were on zero medications vs 17.6% preoperatively (P<0.001); 14.5% of eyes were on ≥2 medications vs 46.7% preoperatively (P<0.001); and 98.2% of eyes maintained or reduced medications vs their preoperative regimen. Favorable safety included no stent-related intraoperative complications; limited and transient postoperative adverse events; and stable CDR, VF, and visual acuity. Three eyes with more advanced disease underwent additional glaucoma surgeries.

Conclusion: iStent inject implantation with cataract surgery significantly and safely reduced medications and IOP in eyes with various types and severities of glaucoma within a multicenter, multi-provider, real-life setting.

Keywords: MIGS; glaucoma; iStent inject; intraocular pressure; medication; microinvasive glaucoma surgery; safety; second-generation.