Evidence based approach to the management of glaucoma
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What is most desirable first up: tube or trab?
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This question was attempted to be answered between 1999 and 2004, in multiple centres in the United States of America
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Patients enrolled were with the following criteria:
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Aged 18 to 85: no paediatric patients
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Patients had undergone either:
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Previous trabeculectomy
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Cataract surgery
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Both
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The pressure control was inadequate, with intra-ocular tension between 18 and 40mmHg, on tolerated medical treatment
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212 eyes of 212 patients were recruited and allocated to the following groups:
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107 = Tubes
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107= Trabs
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Failures defined as:
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IOP more than 21mmHg or less than 5mmHg
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Patients requiring a secondary operation (including trans-scleral diode)
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The pressure not reduced less than 20% below baseline on two consecutive visits after three months
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The five-year data was published in 2012, revealing that at this interval:
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Mean IOP reduction from baseline in the tube group = 10.2mmHg
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Mean IOP reduction from baseline in the trab group = 12.4mmHg
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No statistical significance after three months
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The mean number of drops reduction from baseline:
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1.8 in the tube group
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1.7 in the trab group
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Re-operation rates higher in the trab group:
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9% in the tube group
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29% in the trab group
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Failure rates, significantly higher in the trab group:
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33% in the tube group
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50% in the trab group
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Kaplan Meier survival analysis revealed the cumulative probability of failure at five-years:
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Tube = 29.8%
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Trab = 46.9%
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My interpretation of this paper:
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Patients with failed trabeculectomy should undergo tube surgery
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Can give patients general figures of per annum 10% failure risk of trabs compared to 5% in the tube group
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BUT caution in interpretation:
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Non-virgin eyes, with all eyes having an intervention prior to randomisation
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MMC was administered for 4 minutes, which is not done in clinical practice
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Only Baerveldt 350 tubes were used: whilst I use this in Oxford, surgeons throughout the world use different shunt devices
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Clinically, hypotonous eyes with good vision are not considered a failure: converse to the study design
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Primary TVT study
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This study has not been formally published, rather has been presented at the American Academy (originally October 2016)
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Patients with virgin eyes, with no previous ocular surgery, were randomised to either:
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117 eyes had tube
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108 had trab
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The majority of patients has primary open angle glaucoma, with a mean MD of -14
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The mean IOP at baseline was 23mmHg, on mean triple therapy
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At one year, the following results were observed:
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8% of the trab group had failed
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20% of the tube group had failed
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59% of the trab group had complete success
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14% of the tube group had complete success
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My interpretation of this paper:
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Still a trabeculectomy is gold standard and primary choice for advanced open angle glaucoma
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Assessed the efficacy, safety and cost-effectiveness of clear lens extraction versus YAG iridotomy as the first line management paradigm.
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The study was an International multi-center trial with contributions from Australia (1), China (1), Hong Kong (2), Malaysia (2), Singapore (2) and the UK (22).
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The inclusion criteria included:
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Phakic patients, over the age of 50 years
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PACG, with IOP greater than 30mmHg
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The exclusion criteria were:
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Advanced GON
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Symptomatic cataract
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AACG, with emergency with intervention
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Computer randomisation to two of treatment:
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PI (208 eyes) versus lens extraction (211 eyes)
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18% of the latter group, alos had goniosynechiolysis
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If both eyes were eligible, the eye with the most severe disease was recruited
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Summary of results:
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Economic analyses only done in the UK centres, revealed that lens extraction was initially more expensive:
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PI (£1486)
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Lens extraction (£2467)
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Significant ETDRS loss of more than 10 letters:
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One eye in the lens extraction group
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Three eyes in the PI group
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Further requirement of surgical intervention:
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One eye in the lens extraction group
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24 eyes in the PI group
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Twelve eyes in the PI arm eventually went on to have lens extraction ultimately, within the 60-day timeframe of the study.
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My interpretation of this study:
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In the right patient subgroup of PAC, clear lens extraction is the right evidence based approach. Careful consent it the key.
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A fenestrated microstent, with a curvature that follows the contour of the sclera into the supracilliary space. Hence it increases the aqueous outflow from the AC to the supra-choroidal space, via the uveo-scleral pathway
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This multi-centred, interventional randomised control trial from 24 sites in the United States of America evaluated the two-year safety and efficacy of supra-cilliary micro-stents for treating patients with mild-moderate open angle glaucoma (with untreated pressures of 21-33mmHg) at the same time as cataract extraction.
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505 subjects randomised to:
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131 phaco only
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374 phaco + CYPASS
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Baseline IOP in the two groups:
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Phaco only = 24.5±3.0,
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Phaco and CyPass = 24.4±2.8
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At 24 months, the IOP reduction from baseline:
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Phaco only = 5.4mmHg
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Phaco and CyPass = 7.4mmHg
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The mean medication requirement reduction at 24 months:
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Phaco only = from 1.4±0.9 to 0.2±0.6
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Phaco and CYPASS = from 1.3±1.0 to 0.6±0.8
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My interpretation of this study:
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Patients with mild to moderate glaucoma and an open angle undergoing cataract surgery can be considered for concurrent supra-choroidal shunts
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This study assessed the safety and efficacy of phaco-ECP
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A retrospective case review of 58 patients, including all aetiologies of glaucoma, with a single intervention of phaco + ECP
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Mean pre-surgical IOP was 21.54mmHg
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At 18 months and 24 months, the mean IOP reduced to 14.43 and 14.44mmHg respectively
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There was statistical significance in reduction of IOP at all time points
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This paper did not assess the role of cataract surgery alone
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Interpretation of the paper:
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ECP is a useful adjunct at the time of cataract surgery to manipulate the inflow of pressure
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If pressures of less than 14 are targeted, it will not be the treatment of choice: hence it does not replace trabeculectomy
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A comparison of phaco versus phaco/ECP would be very useful
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Whilst as a fellow at the Western Eye, I was part of the team that looked at three year outcomes in three arms of:
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Phaco alone
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Phaco ECP
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Phaco iStent
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The results will hopefully be published shortly
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This study is an ongoing, phase 4 trial in patients with POAG receiving a Xen implant
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The results commonly quoted are from the interim analysis, up to January 2016
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No incidence of blebitis, endophthalmitis or hypotony noted, although subsequently a report from Lim et al (London) of an endophthalmitis related to an exposed Xen has been documented
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215 patients entered the trial, with a mean pre-operative IOP of 21.4mmHg, on a mean 2.6 topical medications
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At twelve months following Xen implantation, analysing the results of 164 patients:
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Mean IOP = 13.8mmHg
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Mean topical treatment = 0.6 drops
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Percentage of patients with IOP less than 16mmHg = 88
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Cumulative dataset for all Xen implants, reveal the following complications:
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Hyphema = 3.8%
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Secondary surgical procedure related = 3.3%
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My interpretation of this study:
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Xen has an important role in the paradigm of open angle treatment
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Either as a combined or a stand-alone surgical procedure, it should be considered in those patients on multiple drops without advanced glaucomatous optic neuropathy
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The author Gurjeet Jutley acknowledges the contributions of:
Daniel Jackson ST3 Oxford Eye Hospital
Dhakshi Muhundhakumar, ST3 Moorfields Eye Hospital
Zuzana Sipkova, ST6 Oxford Eye Hospital