Artikel
Micro-Invasive Glaucoma Surgery (MIGS) with Trabecular Micro-Bypass Stents and Postoperative Prostaglandin in Open Angle Glaucoma Subjects (P2)
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Autoren
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Gerd Auffarth
- Univ.-Augenklinik Heidelberg, David J Apple Laboratory, Heidelberg
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Florian Kretz
- Univ.-Augenklinik Heidelberg, David J Apple Laboratory, Heidelberg
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MIGS Study group
- Univ.-Augenklinik Heidelberg, David J Apple Laboratory, Heidelberg
| Veröffentlicht: | 18. Oktober 2013 |
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Gliederung
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Purpose: In this study, the Micro-Invasive Glaucoma Surgery (MIGS) Study Group evaluated IOP and safety outcomes following implantation of two trabecular bypass stents as the sole surgical procedure and use of one postoperative medication in open angle glaucoma (OAG) previously not controlled with two medications.
Methods: This prospective study enrolled 41 phakic or pseudophakic eyes with OAG. Subject enrollment criteria included a preoperative regimen of two medications, medicated IOP ≥18 mmHg and ≤30 mmHg, and IOP ≥22 mmHg and ≤38 mmHg following a preoperative medication washout step. Subjects underwent implantation of two trabecular bypass stents via a micro-invasive surgical procedure. Travoprost was prescribed postoperatively. Subjects were evaluated at Day 1, Week 1, and at 1, 3, 6, 12, 13, 18, 24 and 25 months postoperative. The primary efficacy endpoint was ≥20% IOP reduction with reduction of one medication. Clinical parameters included IOP, fundus/optic nerve exam, slit-lamp assessment, gonioscopy, surgical and postoperative complications and best corrected visual acuity.
Results: All eyes have been followed through one year postoperative. The average age was 64 ± 12 years, and 85% of eyes were phakic. All subjects were taking two ocular hypotensive medications prior to surgery. The mean C/D ratio was 0.7 ± 0.1, and 62% of eyes had a C/D ratio of 0.7 or worse. Mean IOP prior to medication washout was 22.3 ± 2.3 mmHg, and IOP after washout was 25.3 ± 1.8 mmHg. All subjects underwent uncomplicated ab interno implantation of two stents through a 1 mm clear corneal incision. Mean IOP on one postoperative ocular hypotensive medication was 14.1 ± 2.6 mmHg at 1 month, 13.9 ± 2.0 mmHg at 3 months, 13.3 ± 1.9 mmHg at 6 months, and 13.0 ± 2.4 mmHg at 12 months. The primary endpoint of ≥20% IOP reduction with reduction of one medication was met in all eyes, with a mean reduction of 48%. All subjects achieved IOP ≤18 mmHg, and 83% achieved IOP ≤15 mmHg.
Conclusion: In this MIGS study, phakic/pseudophakic eyes with OAG not controlled on two medications achieved IOP control with a significantly reduced medication burden through 12 months postoperative after MIGS implantation of two trabecular micro-bypass stents.
