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      The Implications of an Ab Interno Versus Ab Externo Surgical Approach on Outflow Resistance of a Subconjunctival Drainage Device for Intraocular Pressure Control

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          Abstract

          Purpose

          Minimally invasive glaucoma surgery (MIGS) devices that drain into the subconjunctival space can be inserted via an ab externo or ab interno approach. Limited experimental data exists as to the impact of either technique on intraocular pressure (IOP) control. We performed microfluidic studies by using ex vivo rabbit eyes to assess the effect of each approach on outflow resistance of a subconjunctival drainage device for IOP control.

          Methods

          A microfluidic experiment system was designed, consisting of a controlled reservoir of water connected to a pressure pump/flow sensor. The flow rate of water was fixed at 2 μl/min to simulate aqueous humor production. The pressure readings for each approach were recorded at a frequency of 1 Hz. A baseline reading was made before tube insertion into the eye (PEEK tube length set to aim for an initial outflow resistance of 5 to 10 mm Hg/μL/min) followed by measurements for a cumulative 2-ml volume entering the subconjunctival space. Results were adjusted for water viscosity at 37°C and reported as outflow resistance (mm Hg/μL/min ± standard error of mean).

          Results

          Outflow resistance via the ab interno approach was 90.4% higher than with the ab externo approach being measured at 0.80 ± 0.11 mm Hg/μL/min and 0.42 ± 0.05 mm Hg/μL/min, respectively. Bleb formation was observed to be less predictable with the ab interno approach.

          Conclusions

          The ab interno approach demonstrated greater outflow resistance and less predictable bleb formation than the ab externo approach. These results have implications for long-term IOP control and success depending on the approach to device insertion and could be an important consideration for future MIGS devices.

          Translational Relevance

          The effect of the ab interno versus ab externo approach of a MIGS device inserted into the subconjunctival space was assessed. The ab interno approach demonstrated greater outflow resistance and less predictable bleb formation that may have implications for the development of future MIGS devices.

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          Most cited references10

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          Micro-invasive glaucoma surgery: current perspectives and future directions.

          There is an increasing interest and availability of micro-invasive glaucoma surgery (MIGS) procedures. It is important that this increase is supported by sound, peer-reviewed evidence. This article will define MIGS, review relevant publications in the period of annual review and discuss future directions. The results of the pivotal trial comparing a trabecular micro-bypass stent (iStent, Glaukos Corporation, Laguna Hills, CA, USA) combined with phacoemulsification to phacoemulsification alone showed a significantly higher percentage of patients with unmedicated intraocular pressure (IOP) ≤ 21 mmHg, and a comparable safety profile. Initial results are published regarding a second-generation micro-bypass stent (iStent inject, Glaukos Corporation, Laguna Hills, CA, USA), a canalicular scaffold (Hydrus, Ivantis Inc., Irvine, CA, USA) and an ab interno suprachoroidal microstent (CyPass, Transcend Medical, Menlo Park, CA, USA), showing a decrease in mean postoperative IOP. Phaco-Trabectome (Ab interno trabeculectomy Trabectome, NeoMedix Inc., Tustin, CA, USA) was compared to phacotrabeculectomy and showed less IOP reduction, less postoperative complications, and a similar success rate. Similar success rates were found with the comparison of excimer laser trabeculostomy (ELT, AIDA, Glautec AG, Nurnberg, Germany) and selective laser trabeculoplasty. A number of publications review the importance of the location of implantable devices, intraoperative gonioscopy, cost-effectiveness and quality-of-life studies, and randomized clinical trials. MIGS procedures offer reduction in IOP, decrease in dependence on glaucoma medications and an excellent safety profile. Their role within our glaucoma treatment algorithm continues to be clarified and differs from the role of more invasive glaucoma surgeries such as trabeculectomy or glaucoma drainage devices.
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            Ab interno approach to the subconjunctival space using a collagen glaucoma stent.

            This review considers a minimally invasive ab interno approach to glaucoma filtration surgery. Glaucoma filtration surgery can be defined as an attempt to lower intraocular pressure (IOP) by the surgical formation of an artificial drainage pathway from the anterior chamber to the subconjunctival space. Subconjunctival drainage of aqueous fluid has been a cornerstone of glaucoma surgery for more than a century. Varying techniques have been deployed to provide access to this space. Yet, despite numerous innovations in filtering surgery to achieve safe IOP reduction, too many short-term and long-term complications are associated with this surgery. This article describes the development of a new, soft, and permanent ab interno collagen implant (XEN gel stent) to optimize aqueous drainage to the subconjunctival space. Specific characteristics are critical in designing such an implant. Determining the optimum size of the device lumen to avoid hypotony while maximizing long-term outflow is crucial. Other topics discussed include material, length, diameter, flexibility, stability, and biocompatibility of the implant. Preclinical and human eye testing shows that the implant does not seem to occlude inside the lumen and the implant material does not appear to cause tissue reaction in the eye. The ab interno placement of the stent offers an alternative for lowering IOP with a minimally invasive procedure, minimum conjunctival tissue disruption, restricted flow to avoid hypotony, and long-term safety.
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              Fluid Dynamics of a Novel Micro-Fistula Implant for the Surgical Treatment of Glaucoma.

              The purpose of this study was to describe the fluidics of a novel non-valved glaucoma implant designed to prevent hypotony and compare the fluidics of this device with two commonly used non-valved glaucoma devices.
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                Author and article information

                Journal
                Transl Vis Sci Technol
                Transl Vis Sci Technol
                tvst
                Transl Vis Sci Technol
                TVST
                Translational Vision Science & Technology
                The Association for Research in Vision and Ophthalmology
                2164-2591
                May 2019
                28 June 2019
                : 8
                : 3
                : 58
                Affiliations
                [1 ]Chelsea and Westminster Hospital NHS Foundation Trust, London, UK
                [2 ]National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and University College London (UCL) Institute of Ophthalmology, London, UK
                [3 ]UCL Department of Mechanical Engineering, London, UK
                [4 ]UCL School of Pharmacy, London, UK
                Author notes
                Correspondence: Richard M. H. Lee, Department of Ophthalmology, Chelsea and Westminster Hospital NHS Foundation Trust, 369 Fulham Road, London SW10 9NH, UK. e-mail: rmh.lee@ 123456ucl.ac.uk
                Article
                tvst-08-03-38 TVST-18-1128R2
                10.1167/tvst.8.3.58
                6602120
                31293813
                7825ff0c-3ef0-4a26-8a38-9ec51a673c4f
                Copyright 2019 The Authors

                This work is licensed under a Creative Commons Attribution 4.0 International License.

                History
                : 24 September 2018
                : 5 May 2019
                Categories
                Articles

                glaucoma,migs,ab interno,ab externo,surgery,gdd,iop
                glaucoma, migs, ab interno, ab externo, surgery, gdd, iop

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