Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis

Carlo Lavia, Laura Dallorto, Milena Maule, Manuela Ceccarelli, Antonio Maria Fea, Carlo Lavia, Laura Dallorto, Milena Maule, Manuela Ceccarelli, Antonio Maria Fea

Abstract

Background: MIGS have been developed as a surgical alternative for glaucomatous patients.

Purpose: To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification.

Methods: Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280).

Results: Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients' selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported.

Conclusions: Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. PRISMA flow diagram a =…
Fig 1. PRISMA flow diagram a = number of studies excluded for device respected the same order as the main boxes.
Fig 2. Forest plot for comparison in…
Fig 2. Forest plot for comparison in IOP change between study arms at 12-months (divided by device and procedure).
Values expressed in Weighed Mean Difference (WMD).
Fig 3. Forest plot for 12-months difference…
Fig 3. Forest plot for 12-months difference in change in number of glaucoma medications reduction (divided by device and procedure) values expressed in Weighed Mean Difference (WMD).
Fig 4. Forest plot for 12-months IOP…
Fig 4. Forest plot for 12-months IOP reduction (divided by device and procedure).Values expressed in Weighed Mean Difference (WMD).
Fig 5. Forest plot for 12-months number…
Fig 5. Forest plot for 12-months number of medication reduction (divided by device and procedure).
Values expressed in Weighed Mean Difference (WMD).

References

    1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90(3):262–267. doi:
    1. European Glaucoma Society. Terminology and guidelines for glaucoma 4th edition Savona, Italy: Editrice PubliComm, 2014.
    1. Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K et al. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Surv Ophthalmol. 2015;122(7):1308–1316.
    1. Schwartz GF, Quigley HA. Adherence and persistence with glaucoma therapy. Surv Ophthalmol. 2008;53 Suppl1:S57–68.
    1. Schuman JS. Antiglaucoma medications: a review of safety and tolerability issues related to their use. Clin Ther. 2000;22(2):167–208. doi:
    1. Dreer LE, Girkin C, Mansberger SL. Determinants of medication adherence to topical glaucoma therapy. J Glaucoma. 2012;21(4):234–240. doi:
    1. Gedde SJ, Singh K, Schiffman JC, Feuer WJ. Tube Versus Trabeculectomy Study Group. The Tube Versus Trabeculectomy Study: interpretation of results and application to clinical practice. Curr Opin Ophthalmol. 2012;23(2):118–126. doi:
    1. Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL. Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study after five years of follow-up. Am J Ophthalmol. 2012;153(5):789–803. doi:
    1. Francis BA, Singh K, Lin SC, Hodapp E, Jampel HD, Samples JR et al. Novel glaucoma procedures: a report by the American Academy of Ophthalmology. Ophthalmology. 2011;118(7):1466–1480. doi:
    1. Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012;23(2):96–104. doi:
    1. Caprioli J, Kim JH, Friedman DS, Kiang T, Moster MR, Parrish RK 2nd et al. Special Commentary: Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery: Summary of a Joint Meeting of the American Glaucoma Society and the Food and Drug Administration, Washington, DC, February 26, 2014. Ophthalmology. 2015;122(9):1795–1801. doi:
    1. Richter GM, Coleman AL. Minimally invasive glaucoma surgery: current status and future prospects. Clin Ophthalmol. 2016;10:189–206. doi:
    1. Brandão LM, Grieshaber MC. Update on Minimally Invasive Glaucoma Surgery (MIGS) and New Implants. J Ophthalmol. 2013;2013:705915 doi:
    1. Manasses DT, Au L. The New Era of Glaucoma Micro-stent Surgery. Ophthalmol Ther. 2016;5(2):135–146. doi:
    1. Higgins JPT, Altman DG (editors). Chapter 8: assessing risk of bias in included studies In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: .
    1. Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919 doi:
    1. Friedrich JO, Adhikari NK, Beyene J. The ratio of means method as an alternative to mean differences for analyzing continuous outcome variables in meta-analysis: a simulation study. BMC Med Res Methodol. 2008;8:32 doi:
    1. Higgins JP, White IR and Anzures-Cabrera J. Meta-analysis of skewed data: combining results reported on log-transformed or raw scales. Stat Med 2008;27:6072–6092. doi:
    1. Alba AC, Alexander PE, Chang J, MacIsaac J, DeFry S, Guyatt GH. High statistical heterogeneity is more frequent in meta-analysis of continuous than binary outcomes. J Clin Epidemiol. 2016;70:129–135. doi:
    1. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–634.
    1. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994;50(4):1088–1101.
    1. Gonnermann J, Bertelmann E, Pahlitzsch M, Maier AK, Torun N, Klamann MK. Contralateral eye comparison study in MICS & MIGS: Trabectome® vs. iStent inject®. Graefes Arch Clin Exp Ophthalmol. 2017;255(2):359–365. doi:
    1. Khan M, Saheb H, Neelakantan A, Fellman R, Vest Z, Harasymowycz P, et al. Efficacy and safety of combined cataract surgery with 2 trabecular microbypass stents versus ab interno trabeculotomy. J Cataract Refract Surg. 2015;41(8):1716–1724. doi:
    1. Klamann MK, Gonnermann J, Maier AK, Ruokonen PC, Torun N, Joussen AM, et al. Combined clear cornea phacoemulsification in the treatment of pseudoexfoliative glaucoma associated with cataract: significance of trabecular aspiration and ab interno trabeculectomy. Graefes Arch Clin Exp Ophthalmol. 2013;251(9):2195–2199. doi:
    1. Kurji K, Rudnisky CJ, Rayat JS, Arora S, Sandhu S, Damji KF, et al. Phaco-trabectome versus phaco-iStent in patients with open-angle glaucoma. Can J Ophthalmol. 2017;52(1):99–106. doi:
    1. Pahlitzsch M, Gonnermann J, Maier AK, Torun N, Bertelmann E, Joussen AM, et al. Trabeculectomy Ab Interno in Primary Open Angle Glaucoma and Exfoliative Glaucoma. Klin Monbl Augenheilkd. 2015;232(10):1198–1207. doi:
    1. Ting JL, Damji KF, Stiles MC. Trabectome Study Group. Ab interno trabeculectomy: outcomes in exfoliation versus primary open-angle glaucoma. J Cataract Refract Surg. 2012;38(2):315–323. doi:
    1. Pahlitzsch M, Gonnermann J, Maier AK, Bertelmann E, Klamann MK, Erb C. Modified goniotomy as an alternative to trabectome in primary open angle glaucoma and pseudoexfoliation glaucoma: 1 year results. Can J Ophthalmol. 2017;52(1):92–98. doi:
    1. Arriola-Villalobos P, Martínez-de-la-Casa JM, Díaz-Valle D, Fernández-Pérez C, GarcÍa-Sánchez J, García-Feijoó J. Combined iStent trabecular micro-bypass stent implantation and phacoemulsification for coexistent open-angle glaucoma and cataract: a long-term study. Br J Ophthalmol. 2012;96(5):645–649. doi:
    1. Craven ER, Katz LJ, Wells JM, Giamporcaro JE. iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012;38(8):1339–1345. doi:
    1. Fea AM, Consolandi G, Zola M, Pignata G, Cannizzo P, Lavia C, et al. Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up. J Ophthalmol. 2015;2015:795357 doi:
    1. Spiegel D, Wetzel W, Neuhann T, Stuermer J, Hoeh H, Garcia-Feijoo J, et al. Coexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery. Eur J Ophthalmol. 2009;19(3):393–399.
    1. Arriola-Villalobos P, Martinez-de-la-Casa JM, Diaz-Valle D, Morales-Fernandez L, Fernandez-Perez C, Garcia-Feijoo J. Glaukos iStent inject® Trabecular Micro-Bypass Implantation Associated with Cataract Surgery in Patients with Coexisting Cataract and Open-Angle Glaucoma or Ocular Hypertension: A Long-Term Study. J Ophthalmol. 2016;2016:1056573 doi:
    1. Belovay GW, Naqi A, Chan BJ, Rateb M, Ahmed II. Using multiple trabecular micro-bypass stents in cataract patients to treat open-angle glaucoma. J Cataract Refract Surg. 2012;38(11):1911–1917. doi:
    1. Fernández-Barrientos Y, García-Feijoó J, Martínez-de-la-Casa JM, Pablo LE, Fernández-Pérez C, García Sánchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010;51(7):3327–3332. doi:
    1. Katz LJ, Erb C, Carceller GA, Fea AM, Voskanyan L, Wells JM, et al. Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication. Clin Ophthalmol. 2015;9:2313–2320. doi:
    1. Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, et al. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg. 2014;40(8):1295–1300. doi:
    1. Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II, et al. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015;9:2057–2065. doi:
    1. Fea AM, Belda JI, Rękas M, Jünemann A, Chang L, Pablo L, et al. Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014;8:875–882. doi:
    1. Lindstrom R, Lewis R, Hornbeak DM, Voskanyan L, Giamporcaro JE, Hovanesian J, et al. Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up. Adv Ther. 2016;33(11):2082–2090. doi:
    1. Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, et al. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016;5(2):161–172. doi:
    1. Voskanyan L, García-Feijoó J, Belda JI, Fea A, Jünemann A, Baudouin C. Synergy Study Group. Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014;31(2):189–201. doi:
    1. Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, et al. Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts. Ophthalmology. 2016;123(10):2103–2112. doi:
    1. García-Feijoo J, Rau M, Grisanti S, Grisanti S, Höh H, Erb C, et al. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015;159(6):1075–1081. doi:
    1. Pérez-Torregrosa VT, Olate-Pérez Á, Cerdà-Ibáñez M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-Rego A, et al. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol. 2016;91(9):415–21 doi:
    1. Pfeiffer N, Garcia-Feijoo J, Martinez-de-la-Casa JM, Larrosa JM, Fea A, Lemij H, et al. A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma. Ophthalmology. 2015;122(7):1283–1293. doi:
    1. Gandolfi SA, Ungaro N, Ghirardini S, Tardini MG, Mora P. Comparison of Surgical Outcomes between Canaloplasty and Schlemm's Canal Scaffold at 24 Months' Follow-Up. J Ophthalmol. 2016;2016:3410469 doi:
    1. Fea AM, Ahmed II, Lavia C, Mittica P, Consolandi G, Motolese I, et al. Hydrus microstent compared to selective laser trabeculoplasty in primary open angle glaucoma: one year results. Clin Exp Ophthalmol. 2017;45(2):120–127. doi:
    1. Töteberg-Harms M, Hanson JV, Funk J. Cataract surgery combined with excimer laser trabeculotomy to lower intraocular pressure: effectiveness dependent on preoperative IOP. BMC Ophthalmol. 2013;13:24 doi:
    1. Babighian S, Rapizzi E, Galan A. Efficacy and safety of ab interno excimer laser trabeculotomy in primary open-angle glaucoma: two years of follow-up. Ophthalmologica. 2006;220(5):285–290. doi:
    1. Babighian S, Caretti L, Tavolato M, Cian R, Galan A. Excimer laser trabeculotomy vs 180 degrees selective laser trabeculoplasty in primary open-angle glaucoma. A 2-year randomized, controlled trial. Eye (Lond). 2010;24(4):632–638.
    1. Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE. US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011;118(3):459–467. doi:
    1. Arriola-Villalobos P, Martínez-de-la-Casa JM, Díaz-Valle D, García-Vidal SE, Fernández-Pérez C, García-Sánchez J, et al. Mid-term evaluation of the new Glaukos iStent with phacoemulsification in coexistent open-angle glaucoma or ocular hypertension and cataract. Br J Ophthalmol. 2013. October;97(10):1250–5 doi:
    1. Parrish RK, Palmberg P, Sheu WP; XLT Study Group. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. Am J Ophthalmol. 2003;135(5):688–703.
    1. Poley BJ, Lindstrom RL, Samuelson TW, Schulze R Jr. Intraocular pressure reduction after phacoemulsification with intraocular lens implantation in glaucomatous and nonglaucomatous eyes: evaluation of a causal relationship between the natural lens and open-angle glaucoma. J Cataract Refract Surg. 2009; 35(11):1946–55. doi:
    1. Shrivastava A, Singh K. The effect of cataract extraction on intraocular pressure. Curr Opin Ophthalmol. 2010;21(2):118–122. doi:
    1. Melancia D, Abegão Pinto L, Marques-Neves C. Cataract surgery and intraocular pressure. Ophthalmic Res. 2015;53(3):141–148. doi:
    1. Fogagnolo P, Centofanti M, Figus M, Frezzotti P, Fea A, Ligorio P, et al. Short-term changes in intraocular pressure after phacoemulsification in glaucoma patients. Ophthalmologica. 2012;228(3):154–158. doi:
    1. Fea A.M., Dorin G. Laser treatment of glaucoma: Evolution of laser trabeculoplasty techniques. 2008;6(2):45–52
    1. Baudouin C, Labbé A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29(4):312–334. doi:

Source: PubMed

3
구독하다