Abstract
Objective
To evaluate the outcomes of ab interno gelatin microstent implantation alone and in
combination with phacoemulsification for the reduction of intraocular pressure (IOP).
Design
Retrospective cohort study.
Participants
141 eyes of 141 patients with any glaucoma subtype, including refractory glaucoma,
operated in the Centre Hospitalier de l'Université de Montréal (CHUM) from 2015-2018.
Patients were included if they were over 40 years of age and had a preoperative IOP
of >18 mm Hg on maximum tolerated medical therapy.
Methods
All patients received ab-interno microstent implantation (XEN-45, Allergan, Madison,
NJ) with mitomycin C +/- combined phacoemulsification. The primary outcome was complete
surgical success (IOP 6-18 mm Hg and <20% reduction from baseline without IOP medications
or reoperations or cyclophotocoagulation); secondary outcomes included qualified success
allowing for medications, percentage reduction in mean IOP and medications, and reduction
in number of complications, interventions, and reoperations.
Results
Mean follow-up was 30.5 ± 10.2 months (±SD). Mean IOP was 23.3 ± 7.0 mm Hg on 3.4
± 0.8 medications at baseline and 13.3 ± 4.7 mm Hg on 1.9 ± 1.5 medications at 24
months of follow-up (p < 0.001). From 24-month survival analysis estimates, complete success was achieved
in 34.1% of microstent eyes versus 20.7% with combined phacoemulsification (p = 0.02); 79.1% versus 75.1% achieved qualified success, respectively (p = 0.86). Cases with combined phacoemulsification had a higher rate of failure (hazard
ratio [HR] = 1.6, 95% CI 1.1–2.3, p = 0.02). Needling with mitomycin-C or 5-fluorouracil postoperatively occurred in
54 eyes (38.3%). Complications included transient hypotony (10.6%), transient hyphema
(6.4%), macular edema (4.3%), and microstent exposure (2.8%). There were 33 eyes (23.4%)
with reoperations and 14 (9.9%) requiring subsequent cyclophotocoagulation lasers.
Conclusions
Microstent implantation required topical therapy in most cases 24 months following
surgery in primary and refractory glaucoma and, when combined with phacoemulsification,
had a higher risk of failure.
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Canadian Journal of OphthalmologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040 A Systematic Review and Meta-Analysis.Ophthalmology. 2014; 121: 2081-2090https://doi.org/10.1016/j.ophtha.2014.05.013
- Reduction of Intraocular Pressure and Glaucoma Progression: Results From the Early Manifest Glaucoma Trial.JAMA Ophthalmol. 2002; 120: 1268-1279https://doi.org/10.1001/archopht.120.10.1268
- Primary Open-Angle Glaucoma Preferred Practice Pattern® Guidelines.Ophthalmology. 2016; https://doi.org/10.1016/j.ophtha.2015.10.053
- Meta-analysis of the efficacy and safety of combined surgery in the management of eyes with coexisting cataract and open angle glaucoma.Int J Ophthalmol. 2018; 11: 279-286https://doi.org/10.18240/ijo.2018.02.17
- Ciliochoroidal detachment.Surv Ophthalmol. 1983; 27: 281-289https://doi.org/10.1016/0039-6257(83)90228-X
- Endophthalmitis and severe blebitis following trabeculectomy. Epidemiology and risk factors; a single-centre retrospective study.Acta Ophthalmol. 2014; 92: 426-431https://doi.org/10.1111/aos.12257
- Endophthalmitis After Trabeculectomy.JAMA Ophthalmol. 1978; 96: 1017-1018https://doi.org/10.1001/archopht.1978.03910050541009
- Trabeculectomy in the 21st century: A multicenter analysis.Ophthalmology. 2013; https://doi.org/10.1016/j.ophtha.2013.07.049
- Micro-invasive glaucoma surgery: Current perspectives and future directions.Curr Opin Ophthalmol. 2012; https://doi.org/10.1097/ICU.0b013e32834ff1e7
- Glaucoma treatment trends: a review.Can J Ophthalmol. 2017; https://doi.org/10.1016/j.jcjo.2016.07.013
- Ab interno approach to the subconjunctival space using a collagen glaucoma stent.J Cart Refract Surg. 2014; 40: 1301-1306https://doi.org/10.1016/j.jcrs.2014.01.032
- XEN glaucoma treatment system in the management of refractory glaucomas: A short review on trial data and potential role in clinical practice.Clin Ophthalmol. 2018; https://doi.org/10.2147/OPTH.S146919
- Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy.Ophthalmology. 2017; https://doi.org/10.1016/j.ophtha.2017.05.004
- A Retrospective Study of 199 Xen45 Stent Implantations From 2014 to 2016.J Glaucoma. 2019; https://doi.org/10.1097/IJG.0000000000001122
- Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma.Graefe's Arch Clin Exp Ophthalmol. 2019; 257: 983-996https://doi.org/10.1007/s00417-019-04251-z
- The Effect of Phacoemulsification on Intraocular Pressure in Glaucoma Patients: A Report by the American Academy of Ophthalmology.Ophthalmology. 2015; 122: 1294-1307https://doi.org/10.1016/J.OPHTHA.2015.03.021
- Long term effect on intraocular pressure of phacotrabeculectomy compared to trabeculectomy.Br J Ophthalmol. 2003; 87: 850-852https://doi.org/10.1136/bjo.87.7.850
- XEN gel stent: The solution designed by AqueSys®.Surgical Innovations in Glaucoma. 2014; https://doi.org/10.1007/978-1-4614-8348-9_17
- Guidelines on Design and Reporting of Glaucoma Surgical Trials.World Glaucoma Association, Amsterdam, The Netherlands2008
- The XEN45 Gel Stent as a minimally invasive procedure in glaucoma surgery: success rates, risk profile, and rates of re-surgery after 261 surgeries.Graefe's Arch Clin Exp Ophthalmol. 2018; https://doi.org/10.1007/s00417-018-3899-7
- A multi-centre interventional case series of 259 ab-interno Xen gel implants for glaucoma, with and without combined cataract surgery.Eye. 2019; https://doi.org/10.1038/s41433-018-0243-8
- Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies.Ophthalmol Ther. 2019; https://doi.org/10.1007/s40123-019-0193-7
- 1-year outcomes of the Xen45 glaucoma implant.Eye. 2019; https://doi.org/10.1038/s41433-018-0310-1
- XEN Glaucoma Implant with Mitomycin C 1-Year Follow-Up: Result and Complications.J Ophthalmol. 2017; https://doi.org/10.1155/2017/5457246
- Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent.J Ophthalmol. 2017; https://doi.org/10.1155/2017/9364910
- Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months.Am J Ophthalmol. 2017; (Aug 4)https://doi.org/10.1016/j.ajo.2017.07.023
- One-year result of XEN45 implant for glaucoma: Efficacy, safety, and postoperative management.Eye. 2018; https://doi.org/10.1038/eye.2017.162
- Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions.2016https://doi.org/10.1016/j.oftale.2016.05.004 (Arch la Soc Española Oftalmol (English Ed)
- Prospective Evaluation of Standalone XEN Gel Implant and Combined Phacoemulsification-XEN Gel Implant Surgery: 1-Year Results.J Glaucoma. 2018; https://doi.org/10.1097/IJG.0000000000000858
- Combined versus sequential phacotrabeculectomy with intraoperative 5- fluorouracil.J Cataract Refract Surg. 2000; 26: 71-74https://doi.org/10.1016/S0886-3350(99)00334-X
- Trabeculectomy and phacotrabeculectomy, with mitomycin-C, show similar two-year target IOP outcomes.Can J Ophthalmol. 2006; https://doi.org/10.1016/S0008-4182(06)80067-0
- Anterior chamber flare after trabeculectomy and after phacoemulsification.Br J Ophthalmol. 2000; https://doi.org/10.1136/bjo.84.9.1056
- The clinical outcomes of cataract extraction by phacoemulsification in eyes with primary angle-closure glaucoma (PACG) and co-existing cataract: A prospective case series.J Glaucoma. 2006; https://doi.org/10.1097/01.ijg.0000196619.34368.0a
- Ultrasound activates the TM ELAM-1/IL-1/NF-κB response: A potential mechanism for intraocular pressure reduction after phacoemulsification.Investig Ophthalmol Vis Sci. 2003; https://doi.org/10.1167/iovs.02-0631
- Cataract surgery to lower intraocular pressure.Middle East Afr J Ophthalmol. 2009; https://doi.org/10.4103/0974-9233.56222
- Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.Ophthalmology. 2011; https://doi.org/10.1016/j.ophtha.2010.07.007
- Combined cataract extraction and trabeculotomy by the internal approach for coexisting cataract and open-angle glaucoma: initial results.J Cataract Refract Surg. 2008 Jul; 34 (PMID: 18571075): 1096-1103https://doi.org/10.1016/j.jcrs.2008.03.032
- Intraoperative Mitomycin C for glaucoma surgery.Cochrane Database Syst Rev. 2005; https://doi.org/10.1002/14651858.cd002897.pub2
- Three-year follow-up of the Fluorouracil Filtering Surgery Study.Am J Ophthalmol. 1993; https://doi.org/10.1016/S0002-9394(14)73529-9
- Mitomycin C versus 5-Fluorouracil for wound healing in glaucoma surgery.Cochrane Database Syst Rev. 2015; https://doi.org/10.1002/14651858.CD006259.pub2
- The National Survey of Trabeculectomy. III. Early and late complications.Eye. 2002; https://doi.org/10.1038/sj.eye.6700148
- Surgeon perspectives on learning ab-interno gelatin microstent implantation.Can J Ophthalmol. 2018; https://doi.org/10.1016/j.jcjo.2017.10.005
Article Info
Publication History
Published online: March 23, 2022
Accepted:
February 12,
2022
Received in revised form:
January 26,
2022
Received:
October 7,
2021
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.