Top

Trials

Published in:

Open Access 01-12-2024 | Glaucoma | Study protocol

Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial

Authors: Gabriel Ayub, Ticiana De Francesco, Vital Paulino Costa

Published in: Trials | Issue 1/2024

Abstract

Background

Minimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) are two low-cost MIGS procedures that communicate the anterior chamber to Schlemm’s canal. Most of the available publications on MIGS are either case series or retrospective studies, with different study protocols. The aim of this manuscript is to describe a randomized clinical trial (RCT) protocol to compare the long-term intraocular pressure (IOP) control and the safety of both procedures in eyes with primary open-angle glaucoma.

Methods

This is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days.

Discussion

Our study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients’ quality of life.

Trial registration

Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y. Registered on July 29, 2023.

The study was approved by the Ethics Committee of the University of Campinas, Brazil.

Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, et al. Global causes of blindness and distance vision impairment 1990–2020: a systematic review and meta-analysis. Lancet Glob Heal. 2017;5(12):e1221–34.CrossRef

Coleman AL, Miglior S. Risk factors for glaucoma onset and progression. Surv Ophthalmol. 2008;53(6):3–10. https://doi.org/10.1016/j.survophthal.2008.08.006.CrossRef

Ventura MP, Omi CA, Jr. ERS, Tavares IM, Melo LAS de. Primeiro Consenso de Cirurgia de Glaucoma. Sociedade. Sociedade Brasileira de Glaucoma, editor. São Paulo: Sociedade Brasileira de Glaucoma; 2017. Available from: https://www.sbglaucoma.org.br/wp-content/uploads/2017/05/livreto.pdf.

Vasconcellos JPC, Sakata LM, Silva MJL, Costa VP. Segundo Consenso de Glaucoma Primário de Ângulo Fechado. Sociedade Brasileira de Glaucoma. 2012. Available from: https://www.sbglaucoma.org.br/wp-content/uploads/2020/06/consenso04-v2.pdf.

Paranhos Jr. A, Omi CA, Prata Jr. JA, Melo Jr. LAS, Teixeira SH. 3o Consenso Brasileiro de Glaucoma Primário de ângulo Aberto. Sociedade Brasileira de Glaucoma. São Paulo: BestPoint; 2009. 98 p. Available from: https://www.sbglaucoma.org.br/wp-content/uploads/2020/06/consenso03-v2.pdf.

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Surgical complications in the tube versus trabeculectomy study during the first year of follow-up. Am J Ophthalmol. 2007;143(1):31.e2.

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC. Postoperative complications in the tube versus trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):814.e1. https://doi.org/10.1016/j.ajo.2011.10.024.CrossRef

Gillmann K, Mansouri K. Minimally invasive glaucoma surgery: where is the evidence? Asia-Pacific J Ophthalmol. 2020;9(3):203–14.CrossRef

Saheba H, Ahmed IIK. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012;23(2):96–104.CrossRef

10.

Andrew NH, Akkach S, Casson RJ. A review of aqueous outflow resistance and its relevance to microinvasive glaucoma surgery. Surv Ophthalmol. 2020;65(1):18–31. https://doi.org/10.1016/j.survophthal.2019.08.002.CrossRefPubMed

11.

Grover DS, Godfrey DG, Smith O, Feuer WJ, De MontesOca I, Fellman RL. Gonioscopy-assisted transluminal trabeculotomy, ab interno trabeculotomy: technique report and preliminary results. Ophthalmology. 2014;121(4):855–61. https://doi.org/10.1016/j.ophtha.2013.11.001.CrossRefPubMed

12.

Fontana L, De Maria M, Caristia A, Mastrofilippo V, Braglia L, Iannetta D, et al. Comparison of gonioscopy-assisted transluminal trabeculotomy versus trabeculectomy with mitomycin C in patients with open-angle glaucoma. J Glaucoma. 2021;30(1):101–8.CrossRefPubMed

13.

Hirabayashi MT, Lee D, King JT, Thomsen S, An JA. Comparison of surgical outcomes of 360° circumferential trabeculotomy versus sectoral excisional goniotomy with the Kahook Dual Blade at 6 months. Clin Ophthalmol. 2019;13:2017–24.CrossRefPubMedPubMedCentral

14.

Sieck EG, Epstein RS, Kennedy JB, SooHoo JR, Pantcheva MB, Patnaik JL, et al. Outcomes of Kahook Dual Blade goniotomy with and without phacoemulsification cataract extraction. Ophthalmol Glaucoma. 2018;1(1):75–81. https://doi.org/10.1016/j.ogla.2018.06.006.CrossRefPubMed

15.

Elmallah MK, Berdahl JP, Williamson BK, Dorairaj SK, Kahook MY, Gallardo MJ, et al. Twelve-month outcomes of stand-alone excisional goniotomy in mild to severe glaucoma. Clin Ophthalmol. 2020;14:1891–7.CrossRefPubMedPubMedCentral

16.

Bozkurt E, Yenihayat F, Olgun A, Yazıcı AT, Şahbaz İ. The efficacy of gonioscopy-assisted transluminal trabeculectomy combined with phacoemulsification. Int Ophthalmol. 2021;41(1):35–43.CrossRefPubMed

17.

Aktas Z, Ucgul AY, Bektas C, Sahin KS. Surgical outcomes of Prolene gonioscopy-assisted transluminal trabeculotomy in patients with moderate to advanced open-angle glaucoma. J Glaucoma. 2019;28(10):884–8.CrossRefPubMed

18.

Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, De Oca IM, et al. Gonioscopy-assisted transluminal trabeculotomy: an ab interno circumferential trabeculotomy: 24 months follow-up. J Glaucoma. 2018;27(5):393–401.CrossRefPubMed

19.

Rahmatnejad K, Pruzan NL, Amanullah S, Shaukat BA, Resende AF, Waisbourd M, et al. Surgical outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in patients with open-angle glaucoma. J Glaucoma. 2017;26(12):1137–43.CrossRefPubMed

20.

Cubuk MO, Ucgul AY, Unsal E. Gonioscopy-assisted transluminal trabeculotomy as an option after failed trabeculectomy. Int Ophthalmol. 2020;40(8):1923–30. https://doi.org/10.1007/s10792-020-01364-x.CrossRefPubMed

21.

Grover DS, Godfrey DG, Smith O, Shi W, Feuer WJ, Fellman RL. Outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in eyes with prior incisional glaucoma surgery. J Glaucoma. 2017;26(1):41–5.CrossRefPubMed

22.

Salimi A, Nithianandan H, Al Farsi H, Harasymowycz P, Saheb H. Gonioscopy-assisted transluminal trabeculotomy in younger to middle-aged adults: one-year outcomes. Ophthalmol Glaucoma. 2021;4(2):162–72. https://doi.org/10.1016/j.ogla.2020.08.014.CrossRefPubMed

23.

Bektas C, Aktas Z, Ucgul AY, Karamert SS. Prognostic factors affecting the surgical success of gonioscopy-assisted transluminal trabeculotomy. Indian J Ophthalmol. 2021;69(6):1425–9. https://doi.org/10.4103/ijo.IJO_2035_20.CrossRefPubMedPubMedCentral

24.

Chan A, Tetzlaff JM, Altman DG. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2016;158(3):200–7.CrossRef

25.

The Brazilian version of the 25-Item National Eye Institute Visual Function Questionnaire: Translation, reliability and validity. Arquivos Brasileiros de Oftalmologia. 2008;71(4):540–6. https://doi.org/10.1590/S0004-27492008000400014.

26.

Seibold LK, Soohoo JR, Ammar DA, Kahook MY. Preclinical investigation of ab interno trabeculectomy using a novel dual-blade device. Am J Ophthalmol. 2013;155(3):524-529.e2. https://doi.org/10.1016/j.ajo.2012.09.023.CrossRefPubMed

27.

ICMJE | Recommendations | Defining the role of authors and contributors. [cited 2023 Sep 26]. Available from: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html.

28.

Chen PP, Lin SC, Junk AK, Radhakrishnan S, Singh K, Chen TC, et al. The effect of phacoemulsification on intraocular pressure in glaucoma patients: a report by the American Academy of Ophthalmology. Ophthalmology. 2015;122(7):1294–307. https://doi.org/10.1016/j.ophtha.2015.03.021.CrossRefPubMed

29.

Gedde SJ, Chen PP, Heuer DK, Singh K, Wright MM, Feuer WJ, et al. The primary tube versus trabeculectomy study: methodology of a multicenter randomized clinical trial comparing tube shunt surgery and trabeculectomy with mitomycin C. Ophthalmology. 2018;125(5):774–81.CrossRefPubMed

30.

Christakis PG, Kalenak JW, Zurakowski D, Tsai JC, Kammer JA, Harasymowycz PJ, et al. The Ahmed versus Baerveldt study: one-year treatment outcomes. Ophthalmology. 2011;118(11):2180–9. https://doi.org/10.1016/j.ophtha.2011.05.004.CrossRefPubMed

31.

Ahmed IIK, De Francesco T, Rhee D, McCabe C, Flowers B, Gazzard G, et al. Long-term outcomes from the HORIZON randomized trial for a Schlemm’s canal microstent in combination cataract and glaucoma surgery. Ophthalmology. 2022;129(7):742–51. https://doi.org/10.1016/j.ophtha.2022.02.021.CrossRefPubMed

32.

Pathak-Ray V. Minimally invasive glaucoma surgery in India: is it time? Indian J Ophthalmol. 2022;70(5):1443–5.CrossRefPubMedPubMedCentral

33.

Ray V. Commentary: Needle goniotomy in adults: is it a viable minimally-invasive glaucoma surgery option? Indian J Ophthalmol. 2022;70(6):2036–7.CrossRefPubMedPubMedCentral

34.

Greenwood MD, Seibold LK, Radcliffe NM, Dorairaj SK, Aref AA, Román JJ, et al. Goniotomy with a single-use dual blade: short-term results. J Cataract Refract Surg. 2017;43(9):1197–201.CrossRefPubMed

35.

Camras LJ, Yuan F, Fan S, Samuelson TW, Ahmed IK, Schieber AT, et al. A novel Schlemm’s canal scaffold increases outflow facility in a human anterior segment perfusion model. Investig Ophthalmol Vis Sci. 2012;53(10):6115–21.CrossRef

36.

Spiegel D, García-Feijoó J, García-Sánchez J, Lamielle H. Coexistent primary open-angle glaucoma and cataract: preliminary analysis of treatment by cataract surgery and the iStent trabecular micro-bypass stent. Adv Ther. 2008;25(5):453–64.CrossRefPubMed

Title: Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial
Authors: Gabriel Ayub
Ticiana De Francesco
Vital Paulino Costa
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Glaucoma
Trabeculotomy
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-08134-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2024

Designing greener participant-centred trials: an analysis of ‘carbon relevant’ factors within items that influence participants’ decisions about trial recruitment and retention

Ultrasound-guided erector spinae plane block for perioperative analgesia in patients undergoing laparoscopic nephrectomies surgery: a randomized controlled trial

Using hypnotic suggestion in the rehabilitation of working memory capacity after acquired brain injury: study protocol for a randomized controlled trial

Hidden blood loss and the influential factors after minimally invasive treatment of posterior pelvic ring injury with sacroiliac screw

Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial

The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial