Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study)

Xinbo Gao, Aiguo Lv, Fengbin Lin, Ping Lu, Yi Zhang, Wulian Song, Xiaomin Zhu, Hengli Zhang, Mengfei Liao, Yunhe Song, Kun Hu, Yingzhe Zhang, Yuying Peng, Li Tang, Huiping Yuan, Lin Xie, Guangxian Tang, Xin Nie, Ling Jin, Sujie Fan, Xiulan Zhang, TVG study group, Robert N Weinreb, Dennis S C Lam, Keith Barton, Ki-Ho Park, Tin Aung, Xiaohong Liang, Xinbo Gao, Aiguo Lv, Fengbin Lin, Ping Lu, Yi Zhang, Wulian Song, Xiaomin Zhu, Hengli Zhang, Mengfei Liao, Yunhe Song, Kun Hu, Yingzhe Zhang, Yuying Peng, Li Tang, Huiping Yuan, Lin Xie, Guangxian Tang, Xin Nie, Ling Jin, Sujie Fan, Xiulan Zhang, TVG study group, Robert N Weinreb, Dennis S C Lam, Keith Barton, Ki-Ho Park, Tin Aung, Xiaohong Liang

Abstract

Introduction: Primary angle-closure glaucoma (PACG) is a major subtype of glaucoma that accounts for most bilateral glaucoma-related blindness globally. Filtering surgery is a conventional strategy for PACG, yet it has a long learning curve and undesirable disastrous complications. Minimally invasive glaucoma surgery (MIGS) plays an increasing role in the management of glaucoma due to its safer and faster recovery profile; cataract surgery-based MIGS is the most commonly performed such procedure in PACG. However, for patients with a transparent lens or no indications for cataract extraction, incorporation of MIGS into PACG treatment has not yet been reported. Therefore, this multicentre, non-inferiority, randomised controlled clinical trial aims to compare the efficacy and safety of trabeculectomy versus peripheral iridectomy plus an ab interno goniotomy in advanced PACG with no or mild cataracts.

Methods and analysis: This non-inferiority, multicentre, randomised controlled trial will be conducted at seven ophthalmic departments and institutes across China. Eighty-eight patients with no or mild cataracts and advanced PACG will be enrolled and randomised to undergo trabeculectomy or peripheral iridectomy plus ab interno goniotomy. Enrolled patients will undergo comprehensive ophthalmic examinations before and after surgery. The primary outcome is intraocular pressure (IOP) at 12 months postoperatively. The secondary outcomes are cumulative success rate of surgery, surgery-related complications and number of IOP-lowering medications. Participants will be followed up for 36 months postoperatively.

Ethics and dissemination: The study protocol was approved by the ethical committees of the Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ191) and of all subcentres. All participants will be required to provide written informed consent. The results will be published in peer-reviewed journals and disseminated in international academic meetings.

Trial registration number: NCT05163951.

Keywords: glaucoma; medical ophthalmology; ophthalmology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow chart. GSL, goniosynechialysis; GT, goniotomy; SPI, surgical peripheral iridectomy.
Figure 2
Figure 2
Schematic of the two manners of SPI+GSL+GT. SPI at the superior nasal quadrant of the corneal limbus will be carried out, where an oval shadow indicates SPI; the incision is made at the temporal (A) or superior temporal (B) quadrant. GSL and GT will be carried out within a 120° range at the nasal (A) or inferior nasal (B) quadrant of the angle, where a short red line indicates the corneal incision and an arc line indicates an incision range (a chopper is used for GSL; a microhook or microblade is used for GT). GSL, goniosynechialysis; GT, goniotomy; SPI, surgical peripheral iridectomy.
Figure 3
Figure 3
Flow chart showing the postoperative management. GSL, goniosynechialysis; GT, goniotomy; IOP, intraocular pressure; SPI, surgical peripheral iridectomy.

References

    1. Sun X, Dai Y, Chen Y, et al. . Primary angle closure glaucoma: What we know and what we don't know. Prog Retin Eye Res 2017;57:26–45. 10.1016/j.preteyeres.2016.12.003
    1. GBD 2019 Blindness and Vision Impairment Collaborators, Vision Loss Expert Group of the Global Burden of Disease Study . Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to vision 2020: the right to sight: an analysis for the global burden of disease study. Lancet Glob Health 2021;9:e144–60. 10.1016/S2214-109X(20)30489-7
    1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol 2006;90:262–7. 10.1136/bjo.2005.081224
    1. Lai J, Choy BNK, Shum JWH. Management of primary angle-closure glaucoma. Asia Pac J Ophthalmol 2016;5:59–62. 10.1097/APO.0000000000000180
    1. Jampel HD, Musch DC, Gillespie BW, et al. . Perioperative complications of trabeculectomy in the Collaborative initial glaucoma treatment study (CIGTS). Am J Ophthalmol 2005;140:16–22. 10.1016/j.ajo.2005.02.013
    1. Al-Haddad C, Abdulaal M, Al-Moujahed A, et al. . Fornix-based versus limbal-based conjunctival trabeculectomy flaps for glaucoma. Cochrane Database Syst Rev 2015;11:CD009380. 10.1002/14651858.CD009380.pub2
    1. Sawchyn AK, Slabaugh MA. Innovations and adaptations in trabeculectomy. Curr Opin Ophthalmol 2016;27:158–63. 10.1097/ICU.0000000000000236
    1. Hansapinyo L, Choy BNK, Lai JSM, et al. . Phacoemulsification versus phacotrabeculectomy in primary angle-closure glaucoma with cataract: long-term clinical outcomes. J Glaucoma 2020;29:15–23. 10.1097/IJG.0000000000001397
    1. Espandar L, Kassem J. Phacotrabeculectomy meta-analysis. Ophthalmology 2011;118:2096. 10.1016/j.ophtha.2011.03.005
    1. Husain R, Do T, Lai J, et al. . Efficacy of phacoemulsification alone vs phacoemulsification with Goniosynechialysis in patients with primary angle-closure disease: a randomized clinical trial. JAMA Ophthalmol 2019;137:1107–13. 10.1001/jamaophthalmol.2019.2493
    1. Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA 2014;311:1901–11. 10.1001/jama.2014.3192
    1. Hamanaka T, Kasahara K, Takemura T. Histopathology of the trabecular meshwork and Schlemm's canal in primary angle-closure glaucoma. Invest Ophthalmol Vis Sci 2011;52:8849–61. 10.1167/iovs.11-7591
    1. Saheb H, Ahmed IIK. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol 2012;23:96–104. 10.1097/ICU.0b013e32834ff1e7
    1. Gillmann K, Mansouri K. Minimally invasive glaucoma surgery: where is the evidence? Asia Pac J Ophthalmol 2020;9:203–14. 10.1097/APO.0000000000000294
    1. Wu Z, Huang C, Zheng C, et al. . The safety and efficacy of modified minimally invasive trabeculectomy for the treatment of primary chronic angle-closure glaucoma. Eye Sci 2015;30:160–6.
    1. Chen DZ, Sng CCA, Sangtam T, et al. . Phacoemulsification vs phacoemulsification with micro-bypass stent implantation in primary angle closure and primary angle closure glaucoma: a randomized single-masked clinical study. Clin Exp Ophthalmol 2020;48:450–61. 10.1111/ceo.13721
    1. Pathak-Ray V, Choudhari N. Phaco-endocycloplasty versus phacotrabeculectomy in primary angle-closure glaucoma: a prospective randomized study. Ophthalmol Glaucoma 2020;3:434–42. 10.1016/j.ogla.2020.06.006
    1. Minckler D, Mosaed S, Dustin L, et al. . Trabectome (trabeculectomy-internal approach): additional experience and extended follow-up. Trans Am Ophthalmol Soc 2008;106:149–59.
    1. Barry M, Alahmadi MW, Alahmadi M, et al. . The safety of the Kahook dual blade in the surgical treatment of glaucoma. Cureus 2020;12:e6682. 10.7759/cureus.6682
    1. Dorairaj S, Tam MD, Balasubramani GK. Twelve-month outcomes of excisional goniotomy using the Kahook Dual Blade® in eyes with angle-closure glaucoma. Clin Ophthalmol 2019;13:1779–85. 10.2147/OPTH.S221299
    1. Dorairaj S, Tam MD. Kahook dual blade excisional goniotomy and Goniosynechialysis combined with phacoemulsification for angle-closure glaucoma: 6-month results. J Glaucoma 2019;28:643–6. 10.1097/IJG.0000000000001256
    1. Tanito M, Sano I, Ikeda Y, et al. . Short-Term results of microhook ab interno trabeculotomy, a novel minimally invasive glaucoma surgery in Japanese eyes: initial case series. Acta Ophthalmol 2017;95:e354–60. 10.1111/aos.13288
    1. Tanito M, Sugihara K, Tsutsui A, et al. . Midterm results of Microhook ab Interno trabeculotomy in initial 560 eyes with glaucoma. J Clin Med 2021;10:814. 10.3390/jcm10040814
    1. Dorairaj S, Tam MD, Balasubramani GK. Two-Year clinical outcomes of combined phacoemulsification, Goniosynechialysis, and excisional goniotomy for angle-closure glaucoma. Asia Pac J Ophthalmol 2020;10:183–7. 10.1097/APO.0000000000000321
    1. Gupta S, Sethi A, Yadav S, et al. . Safety and efficacy of incisional goniotomy as an adjunct with phacoemulsification in primary angle-closure glaucoma. J Cataract Refract Surg 2021;47:504–11. 10.1097/j.jcrs.0000000000000481
    1. Shokoohi-Rad S, Karimi F, Zarei-Ghanavati S, et al. . Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: a comparative study. Eur J Ophthalmol 2021;31:88–95. 10.1177/1120672119879331
    1. Gedde SJ, Chen PP, Muir KW, et al. . Primary angle-closure disease preferred practice Pattern®. Ophthalmology 2021;128:P30–70. 10.1016/j.ophtha.2020.10.021
    1. Song Y, Song W, Zhang Y, et al. . Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP study). BMJ Open 2021;11:e056876. 10.1136/bmjopen-2021-056876
    1. European Glaucoma Society Terminology and Guidelines for Glaucoma, . European Glaucoma Society Terminology and Guidelines for Glaucoma, 4th Edition - Chapter 2: Classification and terminologySupported by the EGS Foundation: Part 1: Foreword; Introduction; Glossary; Chapter 2 Classification and Terminology. Br J Ophthalmol 2017;101:73–127. 10.1136/bjophthalmol-2016-EGSguideline.002
    1. Tham CCY, Kwong YYY, Baig N, et al. . Phacoemulsification versus trabeculectomy in medically uncontrolled chronic angle-closure glaucoma without cataract. Ophthalmology 2013;120:62–7. 10.1016/j.ophtha.2012.07.021
    1. Roberti G, Oddone F, Agnifili L, et al. . Steroid-Induced glaucoma: epidemiology, pathophysiology, and clinical management. Surv Ophthalmol 2020;65:458–72. 10.1016/j.survophthal.2020.01.002
    1. Cantor LB, Mantravadi A, WuDunn D, et al. . Morphologic classification of filtering blebs after glaucoma filtration surgery: the Indiana bleb appearance grading scale. J Glaucoma 2003;12:266–71. 10.1097/00061198-200306000-00015
    1. Negrel AD, Maul E, Pokharel GP, et al. . Refractive error study in children: sampling and measurement methods for a multi-country survey. Am J Ophthalmol 2000;129:421–6. 10.1016/S0002-9394(99)00455-9
    1. Gedde SJ, Feuer WJ, Lim KS, et al. . Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology 2020;127:333–45. 10.1016/j.ophtha.2019.10.002

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